diclofenac indications/contra

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 865 15307-86-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diclofenac calcium
  • diclofenac diethylamine
  • diclofenac hydroxyethylpyrrolidine
  • diclofenac
  • diclofenamic acid
  • diclofenac sodium
  • diclofenac potassium
  • diclofenac epolamine
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
  • Molecular weight: 296.15
  • Formula: C14H11Cl2NO2
  • CLOGP: 4.58
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -4.82
  • ROTB: 4

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O

Approvals:

DateAgencyCompanyOrphan
July 28, 1988 FDA

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 1751.29 21.82 706 9902 48977 3326274
Melaena 934.52 21.82 274 10334 7038 3368213
Drug hypersensitivity 863.16 21.82 390 10218 35290 3339961
Vomiting 825.85 21.82 513 10095 89018 3286233
Gastric ulcer 794.29 21.82 220 10388 4565 3370686
Drug interaction 776.89 21.82 395 10213 46417 3328834
Gastrointestinal haemorrhage 687.11 21.82 297 10311 24077 3351174
Rash 606.62 21.82 388 10220 70433 3304818
Nausea 604.21 21.82 490 10118 129155 3246096
Haematemesis 598.19 21.82 192 10416 6693 3368558
Haemoglobin decreased 591.64 21.82 286 10322 30008 3345243
Blood creatinine increased 582.49 21.82 256 10352 21562 3353689
Abdominal pain 582.43 21.82 325 10283 45900 3329351
Drug ineffective 530.07 21.82 434 10174 115656 3259595
Ductus arteriosus stenosis foetal 514.22 21.82 84 10524 62 3375189
Abdominal pain upper 506.70 21.82 242 10366 24674 3350577
Pruritus 469.39 21.82 284 10324 46549 3328702
Anaemia 465.13 21.82 298 10310 54035 3321216
Blood urea increased 462.63 21.82 162 10446 7398 3367853
Pyrexia 448.51 21.82 340 10268 80775 3294476
Duodenal ulcer 448.18 21.82 122 10486 2356 3372895
Urticaria 442.19 21.82 231 10377 28496 3346755
Erythema 438.70 21.82 230 10378 28580 3346671
Anaphylactic reaction 436.96 21.82 180 10428 12874 3362377
Angioedema 434.21 21.82 187 10421 14948 3360303
Embolia cutis medicamentosa 430.84 21.82 73 10535 85 3375166
Dyspnoea 425.91 21.82 364 10244 102570 3272681
Suicide attempt 413.00 21.82 183 10425 15664 3359587
Alanine aminotransferase increased 409.77 21.82 206 10402 23434 3351817
C-reactive protein increased 399.67 21.82 154 10454 9229 3366022

Pharmacologic Action:

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SourceCodeDescription
ATC D11AX18 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC M01AB05 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA15 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC S01BC03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC M01AB55 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC S01CC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35493 antipyretic
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA PE N0000008836 Decreased Prostaglandin Production
FDA Chemical/Ingredient N0000175721 Nonsteroidal Anti-inflammatory Compounds
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Actinic keratosis indication 201101007 DOID:8866
Dysmenorrhea indication 266599000
Osteoarthritis indication 396275006 DOID:381
Post-Op Photophobia indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Postoperative Ocular Pain indication
Sprains and Strains indication
Osteoarthritis in Patients at High Ulcer Risk indication
Osteoarthrosis of the Knee indication
Post-Op Ocular Inflammation indication
Keratitis contraindication 5888003 DOID:4677
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Asthenia contraindication 13791008
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Skin ulcer contraindication 46742003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Perforation of cornea contraindication 74895004
Corneal ulcer contraindication 91514001 DOID:8463
Corneal degeneration contraindication 111521006 DOID:1237
Open wound contraindication 125643001
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Cerebrovascular accident contraindication 230690007 DOID:6713
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Corneal Infiltrates contraindication
Gynecological Surgery contraindication
Renal colic off-label use 7093002
Tendinitis off-label use 34840004 DOID:971
Bursitis off-label use 84017003 DOID:2965
Cystoid macular edema off-label use 193387007 DOID:4447
Prevention of Ocular Surgery-Induced Miosis off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.22 acidic
pKa2 0.55 Basic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 6365180 July 15, 2019 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
50MG CAMBIA DEPOMED INC N022165 June 17, 2009 RX FOR SOLUTION ORAL 7759394 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA DEPOMED INC N022165 June 17, 2009 RX FOR SOLUTION ORAL 8097651 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA DEPOMED INC N022165 June 17, 2009 RX FOR SOLUTION ORAL 8927604 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
37.5MG/ML (37.5MG/ML) DYLOJECT JAVELIN PHARMS INC N022396 Dec. 23, 2014 RX SOLUTION INTRAVENOUS 8946292 March 22, 2027 MANAGEMENT OF PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8563613 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8871809 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9066913 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9101591 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9132110 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9168305 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9220784 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339551 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339552 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9539335 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8252838 April 21, 2028 USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 7662858 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 7884095 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 7939518 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 8110606 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 8623920 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR DEPOMED INC N022202 June 16, 2009 RX CAPSULE ORAL 9561200 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9370501 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9375412 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9415029 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
18MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX IROKO PHARMS LLC N204592 Oct. 18, 2013 RX CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON PHARMA N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 7.70 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.52 WOMBAT-PK CHEMBL
UDP-glucuronosyltransferase 1-10 Enzyme Ki 4.55 CHEMBL
Interleukin-8 Cytokine IC50 8.10 CHEMBL
UDP-glucuronosyltransferase 1-6 Enzyme Ki 4.64 CHEMBL
UDP-glucuronosyltransferase 1-7 Enzyme Ki 4.72 CHEMBL
UDP-glucuronosyltransferase 1-9 Enzyme Ki 4.96 CHEMBL
C-X-C chemokine receptor type 1 GPCR IC50 7.92 CHEMBL
UDP-glucuronosyltransferase 1-1 Enzyme Ki 4.28 CHEMBL
Acid-sensing ion channel 3 Ion channel BLOCKER IC50 4 IUPHAR
Aldo-keto reductase family 1 member B10 Enzyme IC50 5.72 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor ANTAGONIST Ki 6.20 IUPHAR
Transthyretin Secreted Kd 6 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 5.59 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.66 CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 5.49 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.52 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 7.17 CHEMBL

External reference:

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IDSource
2714 IUPHAR_LIGAND_ID
4019714 VUID
N0000147806 NUI
C0012091 UMLSCUI
D00903 KEGG_DRUG
CHEMBL139 ChEMBL_ID
144O8QL0L1 UNII
3270 INN_ID
78213-16-8 SECONDARY_CAS_RN
DB00586 DRUGBANK_ID
3033 PUBCHEM_CID
3355 RXNORM
7034005 SNOMEDCT_US
4582 MMSL
d00848 MMSL
363598004 SNOMEDCT_US
4019714 VANDF
N0000008126 NDFRT
N0000147806 NDFRT
004409 NDDF
CHEMBL1034 ChEMBL_ID
CHEBI:47381 CHEBI
CHEMBL1200804 ChEMBL_ID
CHEMBL1201180 ChEMBL_ID
C064142 MESH_SUPPLEMENTAL_RECORD_UI
D004008 MESH_DESCRIPTOR_UI
C000614065 MESH_SUPPLEMENTAL_RECORD_UI
DIF PDB_CHEM_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 20 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 20 sections
VOLTAREN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0478 SOLUTION 1 mg OPHTHALMIC NDA 12 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0803 GEL 30 mg TOPICAL NDA authorized generic 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0844 GEL 30 mg TOPICAL NDA authorized generic 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-0355 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 13 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2474 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6280 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6281 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium 3 Percent HUMAN PRESCRIPTION DRUG LABEL 1 0395-6120 CREAM 300 mg TOPICAL UNAPPROVED DRUG OTHER 3 sections
Dyloject HUMAN PRESCRIPTION DRUG LABEL 1 0409-1068 INJECTION, SOLUTION 37.50 mg INTRAVENOUS NDA 18 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0472-1783 GEL 30 mg TOPICAL ANDA 14 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 19 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 19 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0591-0676 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 14 sections
Diclofenac sodium HUMAN PRESCRIPTION DRUG LABEL 1 0591-2140 SOLUTION 16.05 mg TOPICAL ANDA 20 sections
diclofenac sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-4506 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
diclofenac sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-4507 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-1381 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA AUTHORIZED GENERIC 14 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-1785 TABLET, DELAYED RELEASE 25 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-1787 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-1789 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 13 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0781-5017 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-803 GEL 30 mg TOPICAL NDA 15 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-844 GEL 30 mg TOPICAL NDA 15 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-114 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 13 sections