tetracycline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibiotics, protein-synthesis inhibitors, tetracycline derivatives | 2611 | 60-54-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 1 | g | O |
| 1 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 1.70 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 58 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 74.92 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 77 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.20 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.50 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.78 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 9.40 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 19, 1953 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 3150.64 | 27.71 | 1012 | 2937 | 309675 | 63175398 |
| Urticaria | 61.68 | 27.71 | 63 | 3886 | 165739 | 63319334 |
| Eyelid exfoliation | 58.31 | 27.71 | 10 | 3939 | 164 | 63484909 |
| Skin odour abnormal | 49.94 | 27.71 | 13 | 3936 | 1653 | 63483420 |
| Rash | 43.99 | 27.71 | 103 | 3846 | 560768 | 62924305 |
| Dysphemia | 43.85 | 27.71 | 13 | 3936 | 2662 | 63482411 |
| Muscle tension dysphonia | 43.21 | 27.71 | 8 | 3941 | 206 | 63484867 |
| Wound secretion | 36.88 | 27.71 | 13 | 3936 | 4601 | 63480472 |
| Tuberculin test positive | 36.31 | 27.71 | 12 | 3937 | 3499 | 63481574 |
| Cystitis interstitial | 36.16 | 27.71 | 10 | 3939 | 1598 | 63483475 |
| Vaccination complication | 34.39 | 27.71 | 9 | 3940 | 1168 | 63483905 |
| Food intolerance | 32.93 | 27.71 | 11 | 3938 | 3314 | 63481759 |
| Oral pruritus | 32.67 | 27.71 | 10 | 3939 | 2281 | 63482792 |
| Scar | 31.71 | 27.71 | 16 | 3933 | 13766 | 63471307 |
| Tooth discolouration | 31.18 | 27.71 | 8 | 3941 | 960 | 63484113 |
| Immunisation reaction | 29.34 | 27.71 | 7 | 3942 | 623 | 63484450 |
| Anaphylactic reaction | 27.99 | 27.71 | 27 | 3922 | 66073 | 63419000 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 436.57 | 30.12 | 134 | 768 | 80395 | 34875634 |
| Somnambulism | 38.51 | 30.12 | 10 | 892 | 3062 | 34952967 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 2337.99 | 25.87 | 766 | 3233 | 298150 | 79442239 |
| Eyelid exfoliation | 61.81 | 25.87 | 10 | 3989 | 142 | 79740247 |
| Urticaria | 57.83 | 25.87 | 58 | 3941 | 185143 | 79555246 |
| Skin odour abnormal | 44.72 | 25.87 | 12 | 3987 | 2129 | 79738260 |
| Drug intolerance | 42.65 | 25.87 | 59 | 3940 | 264060 | 79476329 |
| Cystitis interstitial | 39.79 | 25.87 | 10 | 3989 | 1373 | 79739016 |
| Rash | 38.00 | 25.87 | 87 | 3912 | 578271 | 79162118 |
| Drug resistance | 36.45 | 25.87 | 24 | 3975 | 42189 | 79698200 |
| Tuberculin test positive | 35.00 | 25.87 | 11 | 3988 | 3397 | 79736992 |
| Muscle tension dysphonia | 33.21 | 25.87 | 6 | 3993 | 168 | 79740221 |
| Administration site bruise | 32.35 | 25.87 | 6 | 3993 | 195 | 79740194 |
| Wound secretion | 32.19 | 25.87 | 12 | 3987 | 6176 | 79734213 |
| Dysphemia | 30.66 | 25.87 | 10 | 3989 | 3474 | 79736915 |
| Vaccination complication | 28.57 | 25.87 | 7 | 3992 | 866 | 79739523 |
| Scar | 27.54 | 25.87 | 14 | 3985 | 15182 | 79725207 |
| Immunisation reaction | 26.87 | 25.87 | 6 | 3993 | 496 | 79739893 |
| Administration site swelling | 26.72 | 25.87 | 6 | 3993 | 509 | 79739880 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A01AB13 | ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Antiinfectives and antiseptics for local oral treatment |
| ATC | A02BD02 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori |
| ATC | A02BD08 | ALIMENTARY TRACT AND METABOLISM DRUGS FOR ACID RELATED DISORDERS DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) Combinations for eradication of Helicobacter pylori |
| ATC | D06AA04 | DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Tetracycline and derivatives |
| ATC | J01AA07 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE TETRACYCLINES Tetracyclines |
| ATC | J01RA08 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials |
| ATC | S01AA09 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics |
| ATC | S02AA08 | SENSORY ORGANS OTOLOGICALS ANTIINFECTIVES Antiinfectives |
| ATC | S03AA02 | SENSORY ORGANS OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS ANTIINFECTIVES Antiinfectives |
| FDA CS | M0021223 | Tetracyclines |
| FDA EPC | N0000175505 | Tetracycline-class Antimicrobial |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011500 | Protein Synthesis Inhibitors |
| CHEBI has role | CHEBI:33281 | antibiotics |
| CHEBI has role | CHEBI:35441 | antiinfective agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:48001 | protein synthesis inhibitors |
| CHEBI has role | CHEBI:76891 | alanine aminopeptidase inhibitor |
| CHEBI has role | CHEBI:76893 | carboxytripeptidase inhibitor |
| CHEBI has role | CHEBI:35820 | antiprotozoal drugs |
| CHEBI has role | CHEBI:36047 | antibacterial drugs |
| CHEBI has role | CHEBI:76971 | Escherichia coli metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Trachoma | indication | 2576002 | DOID:11265 |
| Actinomycotic infection | indication | 11817007 | DOID:8478 |
| Gonorrhea | indication | 15628003 | DOID:7551 |
| Infection of skin AND/OR subcutaneous tissue | indication | 19824006 | |
| Gingivostomatitis | indication | 20607006 | |
| Acute gonococcal cervicitis | indication | 20943002 | DOID:10615 |
| Granuloma inguinale | indication | 28867007 | DOID:9113 |
| Acute gonococcal urethritis | indication | 29864006 | |
| Acute gonococcal epididymo-orchitis | indication | 30168008 | DOID:10802 |
| Bronchitis | indication | 32398004 | DOID:6132 |
| Neonatal conjunctivitis | indication | 34298002 | DOID:9699 |
| Sinusitis | indication | 36971009 | |
| Gonorrhea of rectum | indication | 42746002 | |
| Acute gonococcal endometritis | indication | 65295003 | DOID:7527 |
| Urinary tract infectious disease | indication | 68566005 | |
| Yaws | indication | 70647001 | DOID:10371 |
| Gonorrhea of pharynx | indication | 74372003 | |
| Rickettsialpox | indication | 75096007 | DOID:11103 |
| Ornithosis | indication | 75116005 | DOID:11262 |
| Brucellosis | indication | 75702008 | DOID:11077 |
| Syphilis | indication | 76272004 | |
| Acne vulgaris | indication | 88616000 | |
| Bacterial conjunctivitis | indication | 128350005 | DOID:9700 |
| Rocky Mountain spotted fever | indication | 186772009 | |
| Q fever | indication | 186788009 | DOID:11100 |
| Lymphogranuloma venereum | indication | 186946009 | DOID:13819 |
| Pneumonia | indication | 233604007 | DOID:552 |
| Inclusion conjunctivitis | indication | 266109000 | |
| Infective otitis media | indication | 312218008 | |
| Bacterial keratitis | indication | 314557000 | |
| Pharyngitis | indication | 405737000 | DOID:2275 |
| Anthrax | indication | 409498004 | DOID:7427 |
| Relapsing fever | indication | 420079008 | DOID:13034 |
| Chlamydia trachomatis infection of genital structure | indication | 428015005 | |
| Typhus Infections | indication | ||
| Sexually Transmitted Epididymo-Orchitis | indication | ||
| Female Urethral Syndrome | indication | ||
| Rectal Chlamydia Trachomatis Infection | indication | ||
| Inflammatory Disease of Female Pelvic Organs | indication | ||
| Superficial Ocular Infection | indication | ||
| Minor Bacterial Skin Infections | indication | ||
| Duodenal Ulcer due to H. Pylori | indication | ||
| Tularemia | off-label use | 19265001 | |
| Enterocolitis | off-label use | 43752006 | |
| Pneumonia due to Mycoplasma pneumoniae | off-label use | 46970008 | |
| Tropical sprue | off-label use | 47384003 | DOID:10607 |
| Plague | off-label use | 58750007 | DOID:3482 |
| Malaria | off-label use | 61462000 | DOID:12365 |
| Blepharoconjunctivitis | off-label use | 68659002 | DOID:2456 |
| Cholangitis | off-label use | 82403002 | DOID:9446 |
| Chlamydial infection | off-label use | 105629000 | |
| Infectious disease of abdomen | off-label use | 128070006 | |
| Ocular rosacea | off-label use | 200933006 | |
| Meibomianitis | off-label use | 309779001 | |
| Infective blepharitis | off-label use | 312219000 | |
| Rosacea | off-label use | 398909004 | DOID:8881 |
| Helicobacter pylori-associated gastritis | off-label use | 708164002 | |
| Chloroquine Resistant Plasmodium Falciparum Malaria | off-label use | ||
| Alcoholism | contraindication | 7200002 | |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Alcohol intoxication | contraindication | 25702006 | |
| Complete atrioventricular block | contraindication | 27885002 | |
| Shock | contraindication | 27942005 | |
| Hypovolemia | contraindication | 28560003 | |
| Glomerulonephritis | contraindication | 36171008 | DOID:2921 |
| Acute hepatitis | contraindication | 37871000 | |
| Hypokalemia | contraindication | 43339004 | |
| Uremia | contraindication | 44730006 | DOID:4676 |
| Stokes-Adams syndrome | contraindication | 46935006 | |
| Chronic heart failure | contraindication | 48447003 | |
| Atrial fibrillation | contraindication | 49436004 | DOID:0060224 |
| Sinus bradycardia | contraindication | 49710005 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Wolff-Parkinson-White pattern | contraindication | 74390002 | DOID:384 |
| Decreased respiratory function | contraindication | 80954004 | |
| Disorder of brain | contraindication | 81308009 | DOID:936 |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Anemia due to enzyme deficiency | contraindication | 111577008 | |
| Deficiency of glucose-6-phosphate dehydrogenase | contraindication | 124134002 | DOID:2862 |
| Seizure disorder | contraindication | 128613002 | |
| Hypomagnesemia | contraindication | 190855004 | |
| Partial atrioventricular block | contraindication | 195039008 | |
| Non-infective meningitis | contraindication | 230155003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pregnancy, function | contraindication | 289908002 | |
| Peripheral nerve disease | contraindication | 302226006 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Hypoxia | contraindication | 389086002 | |
| Pseudomembranous enterocolitis | contraindication | 397683000 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Lidocaine Toxicity | contraindication | ||
| Reduced Hepatic Blood Flow | contraindication |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Cattle | Bacterial pneumonia | Indication |
| Cattle | Bacterial enteritis caused by Escherichia coli | Indication |
| Cattle | Bacterial enteritis caused by Salmonella spp | Indication |
| Cats | Bacterial gastroenteritis caused by Escherichia coli | Indication |
| Cats | Urinary tract infections caused by Staphylococcus species | Indication |
| Cats | Urinary Tract Infections caused by Escherichia coli | Indication |
| Chickens | Synovitis caused by Mycoplasma synoviae | Indication |
| Chickens | Air sacculitis (air-sac disease chronic respiratory disease) caused by Mycoplasma gallisepticum | Indication |
| Chickens | Chronic respiratory disease (CRD or airsac disease) caused by Escherichia coli | Indication |
| Dogs | Bacterial gastroenteritis caused by Escherichia coli | Indication |
| Dogs | Urinary tract infections caused by Staphylococcus species | Indication |
| Dogs | Urinary Tract Infections caused by Escherichia coli | Indication |
| Swine | Bacterial enteritis caused by Escherichia coli | Indication |
| Swine | Bacterial pneumonia associated with Pasteurella species | Indication |
| Swine | Bacterial pneumonia associated with Actinobacillus pleuropneumoniae | Indication |
| Swine | Bacterial pneumonia associated with Klebsiella species | Indication |
| Turkeys | Control of complicating bacterial organisms associated with bluecomb | Indication |
| Turkeys | Infectious synovitis caused by Mycoplasma synoviae | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| Panmycin Tablets | Zoetis Inc. | 1 |
| Albaplex 3x Tablets, Albaplex Tablets | Zoetis Inc. | 2 |
| Panmycin 500 Bolus, Panmycin Hydrochloride | Zoetis Inc. | 1 |
| Panmycin Aquadrops Liquid | Zoetis Inc. | 1 |
| Tetrachel-Vet Drops, Tetrachel-Vet Syrup | Zoetis Inc. | 1 |
| Tetrachel-Vet Tablets 100 | Zoetis Inc. | 1 |
| Tetrachel-Vet Capsules 500 | Zoetis Inc. | 1 |
| Delta Albaplex 3x Tablets, Delta Albaplex Tablets | Zoetis Inc. | 3 |
| Albaplex Capsules | Zoetis Inc. | 2 |
| Tetracycline-Vet Capsules 250 | Zoetis Inc. | 1 |
| Tetracyn Ointment | Zoetis Inc. | 1 |
| Tetracycline Soluble Powder | Zoetis Inc. | 1 |
| Tetracycline | Zoetis Inc. | 1 |
| Tet-Sol 10, Tet-Sol 324 | Huvepharma EOOD | 1 |
| Polyotic | Huvepharma EOOD | 1 |
| Polyotic Oblets | Zoetis Inc. | 1 |
| Panmycin Capsules | Zoetis Inc. | 1 |
| Tetra-Sal | Zoetis Inc. | 1 |
| Polyotic Soluble Powder Concentrate | Zoetis Inc. | 1 |
| TetraSure 324 | Phibro Animal Health Corp. | 1 |
| SOLU-TET | Zoetis Inc. | 1 |
| Tetra-Bac 324 | Huvepharma EOOD | 1 |
| Tetracycline HCL Powder, Tetracycline Hydrochloride Soluble Powder-324 | Quo Vademus LLC | 1 |
| Tetrasol Soluble Powder | Med-Pharmex Inc. | 1 |
| TetraMed 324 HCA | Bimeda Animal Health Limited | 1 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.26 | acidic |
| pKa2 | 7.44 | acidic |
| pKa3 | 8.06 | acidic |
| pKa4 | 11.92 | acidic |
| pKa5 | 12.84 | acidic |
| pKa6 | 13.45 | acidic |
| pKa7 | 9.49 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 140MG;125MG;125MG | BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | RICONPHARMA LLC | A217511 | July 3, 2023 | RX | CAPSULE | ORAL | Dec. 29, 2023 | COMPETITIVE GENERIC THERAPY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Alpha-synuclein | Transporter | IC50 | 5.22 | CHEMBL | |||||
| 30S ribosomal protein S4 | Ribosomal protein | WOMBAT-PK | |||||||
| 30S ribosomal protein S9 | Ribosomal protein | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4017625 | VUID |
| N0000146005 | NUI |
| D00201 | KEGG_DRUG |
| 1336-20-5 | SECONDARY_CAS_RN |
| 64-75-5 | SECONDARY_CAS_RN |
| 4017625 | VANDF |
| 4017626 | VANDF |
| C0039644 | UMLSCUI |
| CHEBI:27902 | CHEBI |
| TAC | PDB_CHEM_ID |
| CHEMBL1440 | ChEMBL_ID |
| CHEMBL1201071 | ChEMBL_ID |
| CHEMBL454950 | ChEMBL_ID |
| D013752 | MESH_DESCRIPTOR_UI |
| DB00759 | DRUGBANK_ID |
| 10927 | IUPHAR_LIGAND_ID |
| 298 | INN_ID |
| F8VB5M810T | UNII |
| 54675776 | PUBCHEM_CID |
| DB09550 | DRUGBANK_ID |
| 10395 | RXNORM |
| 2048 | MMSL |
| 5561 | MMSL |
| 6463 | MMSL |
| d00041 | MMSL |
| 002738 | NDDF |
| 002739 | NDDF |
| 002740 | NDDF |
| 16355005 | SNOMEDCT_US |
| 372809001 | SNOMEDCT_US |
| 66261008 | SNOMEDCT_US |
| 96075004 | SNOMEDCT_US |
| 13930-32-0 | SECONDARY_CAS_RN |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0440-8505 | CAPSULE | 250 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2474 | CAPSULE | 250 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2474 | CAPSULE | 250 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2475 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2475 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-590 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-216 | CAPSULE | 250 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-217 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-302 | CAPSULE | 250 mg | ORAL | ANDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-640 | CAPSULE | 500 mg | ORAL | ANDA | 23 sections |
| tetracycline hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-017 | CAPSULE | 250 mg | ORAL | NDA | 21 sections |
| tetracycline hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-018 | CAPSULE | 500 mg | ORAL | NDA | 21 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-766 | CAPSULE | 250 mg | ORAL | ANDA | 13 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-766 | CAPSULE | 250 mg | ORAL | ANDA | 13 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-767 | CAPSULE | 500 mg | ORAL | ANDA | 13 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 23155-767 | CAPSULE | 500 mg | ORAL | ANDA | 13 sections |
| Diabecline | HUMAN OTC DRUG LABEL | 1 | 24471-200 | OINTMENT | 30 mg | TOPICAL | OTC monograph final | 13 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-798 | CAPSULE | 250 mg | ORAL | NDA | 23 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-799 | CAPSULE | 500 mg | ORAL | NDA | 23 sections |
| TETRA-ABC | HUMAN OTC DRUG LABEL | 1 | 43074-103 | OINTMENT | 0.03 mg | TOPICAL | OTC monograph final | 24 sections |
| Dyabetex | HUMAN OTC DRUG LABEL | 1 | 43074-108 | OINTMENT | 0.03 mg | TOPICAL | OTC monograph final | 24 sections |
| Diabecline | HUMAN OTC DRUG LABEL | 1 | 43074-112 | OINTMENT | 30 mg | TOPICAL | OTC monograph final | 13 sections |
| Tetracycline-ABC | HUMAN OTC DRUG LABEL | 1 | 43074-115 | OINTMENT | 0.03 mg | TOPICAL | OTC monograph final | 12 sections |
| Acnecycline | HUMAN OTC DRUG LABEL | 1 | 43074-116 | OINTMENT | 0.03 mg | TOPICAL | OTC monograph final | 12 sections |
| TetraStem | HUMAN OTC DRUG LABEL | 1 | 43074-301 | OINTMENT | 30 mg | TOPICAL | OTC monograph final | 13 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-508 | CAPSULE | 250 mg | ORAL | ANDA | 26 sections |
| Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-509 | CAPSULE | 500 mg | ORAL | ANDA | 26 sections |
| Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 3 | 49884-151 | CAPSULE | 125 mg | ORAL | ANDA | 27 sections |
| SUMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-732 | TABLET, FILM COATED | 250 mg | ORAL | ANDA | 23 sections |
| SUMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-733 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 23 sections |