theophylline Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| N-methylated xanthine derivatives | 2620 | 58-55-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A plant genus of the family ASTERACEAE. The name "prickly burweed" is sometimes used but causes confusion with AMSINCKIA.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
| 0.40 | g | P |
| 0.40 | g | R |
| 0.60 | g | O |
| 0.60 | g | P |
| 0.60 | g | R |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 8.30 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 18 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 48.12 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 0.51 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.86 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.61 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 7.20 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 19, 1940 | FDA | GD SEARLE LLC |
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 354.91 | 51.60 | 102 | 560 | 32652 | 2324771 |
| Asthma | 273.94 | 51.60 | 67 | 595 | 11247 | 2346176 |
| Vomiting | 172.44 | 51.60 | 73 | 589 | 71529 | 2285894 |
| Tachycardia | 153.22 | 51.60 | 46 | 616 | 16363 | 2341060 |
| Dyspnoea | 139.96 | 51.60 | 65 | 597 | 78668 | 2278755 |
| Drug hypersensitivity | 129.96 | 51.60 | 53 | 609 | 46590 | 2310833 |
| Hypokalaemia | 112.84 | 51.60 | 33 | 629 | 10621 | 2346802 |
| Intentional overdose | 110.86 | 51.60 | 33 | 629 | 11288 | 2346135 |
| Respiratory acidosis | 109.23 | 51.60 | 20 | 642 | 801 | 2356622 |
| Lung hyperinflation | 105.88 | 51.60 | 15 | 647 | 109 | 2357314 |
| Wheezing | 105.28 | 51.60 | 28 | 634 | 6356 | 2351067 |
| Drug level increased | 100.84 | 51.60 | 23 | 639 | 2764 | 2354659 |
| Spleen congestion | 99.32 | 51.60 | 13 | 649 | 47 | 2357376 |
| Aortic valve calcification | 95.10 | 51.60 | 13 | 649 | 70 | 2357353 |
| Airway peak pressure increased | 94.71 | 51.60 | 12 | 650 | 31 | 2357392 |
| Drug interaction | 94.24 | 51.60 | 37 | 625 | 29126 | 2328297 |
| Overdose | 92.55 | 51.60 | 33 | 629 | 19874 | 2337549 |
| PCO2 increased | 92.17 | 51.60 | 14 | 648 | 172 | 2357251 |
| Blood bicarbonate decreased | 91.60 | 51.60 | 16 | 646 | 487 | 2356936 |
| Blood lactic acid increased | 89.44 | 51.60 | 17 | 645 | 834 | 2356589 |
| Status asthmaticus | 86.49 | 51.60 | 13 | 649 | 148 | 2357275 |
| PO2 decreased | 84.58 | 51.60 | 14 | 648 | 306 | 2357117 |
| Hypercapnia | 83.50 | 51.60 | 15 | 647 | 537 | 2356886 |
| Blood pH decreased | 78.60 | 51.60 | 14 | 648 | 477 | 2356946 |
| Seizure | 75.26 | 51.60 | 30 | 632 | 24436 | 2332987 |
| Pulmonary congestion | 75.25 | 51.60 | 17 | 645 | 1948 | 2355475 |
| Respiratory rate increased | 73.94 | 51.60 | 16 | 646 | 1504 | 2355919 |
| Respiratory failure | 72.63 | 51.60 | 25 | 637 | 13503 | 2343920 |
| Cardiomegaly | 71.90 | 51.60 | 17 | 645 | 2379 | 2355044 |
| Rhabdomyolysis | 71.85 | 51.60 | 21 | 641 | 6683 | 2350740 |
| Sinus tachycardia | 71.30 | 51.60 | 18 | 644 | 3307 | 2354116 |
| Somnolence | 69.44 | 51.60 | 28 | 634 | 23457 | 2333966 |
| Blood creatine phosphokinase increased | 68.11 | 51.60 | 19 | 643 | 5117 | 2352306 |
| Nausea | 65.84 | 51.60 | 45 | 617 | 112144 | 2245279 |
| Hypotension | 63.90 | 51.60 | 29 | 633 | 32407 | 2325016 |
| Dehydration | 63.89 | 51.60 | 26 | 636 | 22269 | 2335154 |
| Aortic valve stenosis | 63.05 | 51.60 | 11 | 651 | 331 | 2357092 |
| Toxic epidermal necrolysis | 62.37 | 51.60 | 16 | 646 | 3128 | 2354295 |
| Skin infection | 57.97 | 51.60 | 13 | 649 | 1437 | 2355986 |
| Cyanosis | 57.31 | 51.60 | 15 | 647 | 3170 | 2354253 |
| Depressed level of consciousness | 56.57 | 51.60 | 18 | 644 | 7586 | 2349837 |
| Peritonitis bacterial | 55.39 | 51.60 | 11 | 651 | 676 | 2356747 |
| Oxygen saturation decreased | 52.50 | 51.60 | 17 | 645 | 7569 | 2349854 |
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 151.53 | 54.91 | 55 | 440 | 29086 | 1717200 |
| Tachycardia | 147.23 | 54.91 | 44 | 451 | 12584 | 1733702 |
| Asthma | 146.75 | 54.91 | 36 | 459 | 4868 | 1741418 |
| Dyspnoea | 111.07 | 54.91 | 52 | 443 | 52007 | 1694279 |
| Seizure | 103.47 | 54.91 | 38 | 457 | 20403 | 1725883 |
| Hypotension | 86.39 | 54.91 | 37 | 458 | 29617 | 1716669 |
| Foetal malformation | 77.94 | 54.91 | 10 | 485 | 22 | 1746264 |
| Trisomy 18 | 74.10 | 54.91 | 10 | 485 | 37 | 1746249 |
| Mental disability | 73.89 | 54.91 | 10 | 485 | 38 | 1746248 |
| Completed suicide | 66.59 | 54.91 | 26 | 469 | 16286 | 1730000 |
| Supraventricular tachycardia | 63.89 | 54.91 | 15 | 480 | 1648 | 1744638 |
| Tachyarrhythmia | 61.88 | 54.91 | 12 | 483 | 527 | 1745759 |
| Vomiting | 59.37 | 54.91 | 31 | 464 | 38284 | 1708002 |
| Atrial fibrillation | 57.80 | 54.91 | 23 | 472 | 15088 | 1731198 |
| Tachycardia foetal | 55.53 | 54.91 | 8 | 487 | 52 | 1746234 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | R03DA04 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines |
| ATC | R03DA05 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines |
| ATC | R03DA54 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines |
| ATC | R03DA55 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines |
| ATC | R03DA74 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines |
| ATC | R03DB04 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines and adrenergics |
| ATC | R03DB05 | RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES Xanthines and adrenergics |
| FDA EPC | N0000175790 | Methylxanthine |
| FDA CS | M0023046 | Xanthines |
| CHEBI has role | CHEBI:51371 | muscle relaxant |
| CHEBI has role | CHEBI:35523 | bronchodilator agent |
| CHEBI has role | CHEBI:35620 | vasodilator agent |
| CHEBI has role | CHEBI:50846 | immunomodulator |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:49167 | anti-asthmatic drug |
| MeSH PA | D018927 | Anti-Asthmatic Agents |
| MeSH PA | D001993 | Bronchodilator Agents |
| MeSH PA | D002316 | Cardiotonic Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D010726 | Phosphodiesterase Inhibitors |
| MeSH PA | D020011 | Protective Agents |
| MeSH PA | D058914 | Purinergic Antagonists |
| MeSH PA | D058915 | Purinergic P1 Receptor Antagonists |
| MeSH PA | D019141 | Respiratory System Agents |
| MeSH PA | D014665 | Vasodilator Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Bronchospasm | indication | 4386001 | |
| Disorder of lung | indication | 19829001 | DOID:850 |
| Bronchitis | indication | 32398004 | DOID:6132 |
| Pulmonary emphysema | indication | 87433001 | |
| Asthma | indication | 195967001 | DOID:2841 |
| Asthma night-time symptoms | indication | 395022009 | |
| Asthma management | indication | 406162001 | |
| Acute exacerbation of asthma | indication | 708038006 | |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | indication | 10692761000119107 | |
| COPD Associated with Chronic Bronchitis | indication | ||
| Chronic Obstructive Pulmonary Disease with Bronchospasms | indication | ||
| Apnea in the newborn | off-label use | 13094009 | |
| Neonatal Mixed Apnea | off-label use | ||
| Goiter | contraindication | 3716002 | DOID:12176 |
| Tachyarrhythmia | contraindication | 6285003 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Alcoholism | contraindication | 7200002 | |
| Hyperammonemia | contraindication | 9360008 | |
| Peptic ulcer | contraindication | 13200003 | DOID:750 |
| Hepatic encephalopathy | contraindication | 13920009 | DOID:13413 |
| Hyperkalemia | contraindication | 14140009 | |
| Pulmonary edema | contraindication | 19242006 | DOID:11396 |
| Hashimoto thyroiditis | contraindication | 21983002 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Acute tuberculosis | contraindication | 25629007 | |
| Shock | contraindication | 27942005 | |
| Hyperthyroidism | contraindication | 34486009 | DOID:7998 |
| Depressive disorder | contraindication | 35489007 | |
| Acute hepatitis | contraindication | 37871000 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Third trimester pregnancy | contraindication | 41587001 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Chronic heart failure | contraindication | 48447003 | |
| Disorder of cardiovascular system | contraindication | 49601007 | DOID:1287 |
| Coronary arteriosclerosis | contraindication | 53741008 | DOID:3393 |
| Multiple organ failure | contraindication | 57653000 | |
| Hepatic failure | contraindication | 59927004 | |
| Poisoning by phenobarbital | contraindication | 64921004 | |
| Substance abuse | contraindication | 66214007 | |
| Psychotic disorder | contraindication | 69322001 | |
| Hepatic coma | contraindication | 72836002 | DOID:12550 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Sleep apnea | contraindication | 73430006 | DOID:0050847 |
| Chronic idiopathic constipation | contraindication | 82934008 | |
| Cor pulmonale | contraindication | 83291003 | DOID:8515 |
| Open-angle glaucoma | contraindication | 84494001 | DOID:1067 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Dermatitis herpetiformis | contraindication | 111196000 | DOID:8505 |
| Seizure disorder | contraindication | 128613002 | |
| Cystic fibrosis | contraindication | 190905008 | DOID:1485 |
| Angina pectoris | contraindication | 194828000 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Bladder outflow obstruction | contraindication | 236645006 | |
| Sepsis syndrome | contraindication | 238150007 | |
| Hypocomplementemic urticarial vasculitis | contraindication | 239945009 | |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Dyspnea | contraindication | 267036007 | |
| Retention of urine | contraindication | 267064002 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Continuous fever | contraindication | 271751000 | |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Smoking cessation assistance | contraindication | 384742004 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Chronic myocardial ischemia | contraindication | 413844008 | DOID:3393 |
| Disorder of coronary artery | contraindication | 414024009 | |
| Myocardial ischemia | contraindication | 414795007 | DOID:3393 |
| Porphyria | contraindication | 418470004 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Severe Hypoxemia | contraindication | ||
| Theophylline Toxicity | contraindication |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.46 | acidic |
| pKa2 | 3.01 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Adenosine receptor A1 | GPCR | ANTAGONIST | Ki | 9.22 | CHEMBL | CHEMBL | |||
| Adenosine receptor A2b | GPCR | ANTAGONIST | Ki | 5.57 | CHEMBL | CHEMBL | |||
| cGMP-inhibited 3',5'-cyclic phosphodiesterase A | Enzyme | INHIBITOR | Ki | 3.85 | WOMBAT-PK | CHEMBL | |||
| Adenosine receptor A2a | GPCR | ANTAGONIST | Ki | 9.22 | CHEMBL | CHEMBL | |||
| cAMP-specific 3',5'-cyclic phosphodiesterase 4A | Enzyme | INHIBITOR | Ki | 4.11 | WOMBAT-PK | CHEMBL | |||
| Alkaline phosphatase, tissue-nonspecific isozyme | Enzyme | Ki | 4.09 | CHEMBL | |||||
| Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform | Kinase | IC50 | 4.12 | CHEMBL | |||||
| Adenosine receptor A3 | GPCR | ANTAGONIST | Ki | 7.85 | CHEMBL | ||||
| Adenosine A2a receptor | Unclassified | Ki | 4.89 | CHEMBL | |||||
| Adenosine receptor A2a | GPCR | Ki | 5.17 | CHEMBL | |||||
| Adenosine A2 receptor | GPCR | Ki | 5.88 | CHEMBL | |||||
| Heart phosphodiesterase | Enzyme | IC50 | 4.04 | CHEMBL | |||||
| Adenosine receptor A3 | GPCR | Ki | 4.07 | CHEMBL | |||||
| Uncharacterized protein | Enzyme | Ki | 4.11 | CHEMBL | |||||
| Adenosine A2b receptor | GPCR | Ki | 4.82 | CHEMBL | |||||
| Adenosine receptor A1 | GPCR | Ki | 5.01 | CHEMBL | |||||
| Adenosine receptor | GPCR | Ki | 4.70 | CHEMBL | |||||
| Adenosine receptor A2b | Unclassified | ANTAGONIST | Ki | 5.25 | IUPHAR | ||||
| Adenosine receptor A1 | GPCR | Ki | 5.42 | CHEMBL | |||||
| Adenosine receptor A1 | GPCR | Ki | 6.15 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D000628 | MESH_DESCRIPTOR_UI |
| 4018056 | VUID |
| N0000146397 | NUI |
| C0002575 | UMLSCUI |
| D00227 | KEGG_DRUG |
| 0I55128JYK | UNII |
| 376 | INN_ID |
| 317-34-0 | SECONDARY_CAS_RN |
| 66493003 | SNOMEDCT_US |
| 4018129 | VANDF |
| 2086 | MMSL |
| 10438 | RXNORM |
| 372810006 | SNOMEDCT_US |
| 5563 | MMSL |
| d00142 | MMSL |
| 4173 | MMSL |
| 000602 | NDDF |
| 2153 | PUBCHEM_CID |
| CHEBI:28177 | CHEBI |
| CHEMBL190 | ChEMBL_ID |
| DB00277 | DRUGBANK_ID |
| CHEMBL1200578 | ChEMBL_ID |
| TEP | PDB_CHEM_ID |
| CHEMBL1370561 | ChEMBL_ID |
| D013806 | MESH_DESCRIPTOR_UI |
| D031210 | MESH_DESCRIPTOR_UI |
| 413 | IUPHAR_LIGAND_ID |
| DB01223 | DRUGBANK_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| THEOPHYLLINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0820 | SOLUTION | 80 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-4794 | SOLUTION | 80 mg | ORAL | ANDA | 12 sections |
| THEOPHYLLINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-4820 | SOLUTION | 80 mg | ORAL | ANDA | 12 sections |
| Theophylline in Dextrose | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0264-9554 | INJECTION, SOLUTION | 80 mg | INTRAVENOUS | NDA | 13 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0486 | TABLET, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0487 | TABLET, EXTENDED RELEASE | 600 mg | ORAL | ANDA | 12 sections |
| Aminophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-5921 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| Aminophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-5922 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| Theophylline Extended Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-1590 | TABLET, EXTENDED RELEASE | 300 mg | ORAL | ANDA | 12 sections |
| Theophylline Extended Release | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-2503 | TABLET, EXTENDED RELEASE | 200 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-604 | SOLUTION | 80 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0038 | SOLUTION | 80 mg | ORAL | ANDA | 11 sections |
| ELIXOPHYLLIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17856-0644 | LIQUID | 80 mg | ORAL | ANDA | 10 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 27808-033 | SOLUTION | 80 mg | ORAL | ANDA | 11 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29033-001 | TABLET, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29033-002 | TABLET, EXTENDED RELEASE | 600 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42858-701 | TABLET, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 13 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42858-702 | TABLET, EXTENDED RELEASE | 600 mg | ORAL | ANDA | 13 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 46708-025 | TABLET, EXTENDED RELEASE | 300 mg | ORAL | ANDA | 11 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 46708-026 | TABLET, EXTENDED RELEASE | 450 mg | ORAL | ANDA | 11 sections |
| AMINOPHYLLINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51662-1204 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| AMINOPHYLLINE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51662-1341 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| Theo-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52244-100 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | ANDA | 12 sections |
| Theo-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52244-200 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | ANDA | 12 sections |
| Theo-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52244-300 | CAPSULE, EXTENDED RELEASE | 300 mg | ORAL | ANDA | 12 sections |
| Theo-24 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52244-400 | CAPSULE, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 12 sections |
| Aminophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52584-921 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| Aminophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52584-922 | INJECTION, SOLUTION | 25 mg | INTRAVENOUS | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0315 | TABLET, EXTENDED RELEASE | 200 mg | ORAL | ANDA | 12 sections |
| Theophylline | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0316 | TABLET, EXTENDED RELEASE | 300 mg | ORAL | ANDA | 12 sections |