Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Cimetidine Hydrochloride Solution, 300 mg (base)/5 mL, Copley Pharmaceutical ANDA 74-859 7/9/98 7/10/98 Cimetidine Hydrochloride Solution, 300 mg (base)/5 mL Duramed ANDA 75-110 6/18/98 6/18/98 Cimetidine Hydrochloride Solution, 300 mg (base)/5 mL, Novex Pharma ANDA 75-560 3/15/00 Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, & 800 mg Apotex Corp. ANDA 74-890 12/18/98 12/18/98 1/14/02 Cimetidine Tablets, 200 mg, OTC Apotex ANDA 74-948/S1 7/26/02 Cimetidine Tablets, 100 mg, OTC Apotex ANDA 74-948 6/19/98 6/19/98 Cimetidine Tablets, 100 mg, OTC L. Perrigo Company ANDA 74-972 6/19/98 6/23/98 Cimetidine Tablets, 100 mg, OTCTentatively approved Novopharm ANDA 74-961 5/29/98 6/3/98 Cimetidine Tablets, 100 mg, OTC Pharmaceutical Formulations ANDA 74-963 6/19/98 6/19/98 Cimetidine Tablets, 100 mg, 200 mg, OTC LEK USA ANDA 75-122 6/19/98 6/23/98 Cimetidine Tablets USP, 200 mg, OTC L. Perrigo Company ANDA 75-285 10/29/98 10/29/98 9/25/02 Cimetidine Tablets USP, 200 mg Danbury Pharmacal ANDA 75-425 7/29/99 8/6/99 Cimetidine Tablets USP, 200 mg, OTC Zenith Goldline ANDA 75-345 Tagamet HB 200 (cimetidine) Suspension, oral suspension, OTC. SmithKline Beecham Consumer Healthcare. NDA 20-951 CIMETIDINE Tablet; 300MG CIMETIDINE CLONMEL 074340 CIMETIDINE Tablet; 400MG CIMETIDINE CLONMEL 074339 CIMETIDINE Tablet; 800MG CIMETIDINE CLONMEL 074281 CIMETIDINE Tablet; 200MG CIMETIDINE ENDO 074281 CIMETIDINE Tablet; 300MG CIMETIDINE ENDO 074281 CIMETIDINE Tablet; 400MG CIMETIDINE ENDO 074329 CIMETIDINE Tablet; 800MG CIMETIDINE ENDO 074100 CIMETIDINE Tablet; 200MG CIMETIDINE Geneva 074100 CIMETIDINE Tablet; 300MG CIMETIDINE Geneva 074100 CIMETIDINE Tablet; 400MG CIMETIDINE Geneva 074100 CIMETIDINE Tablet; 800MG CIMETIDINE Geneva 074506 CIMETIDINE Tablet; 200MG CIMETIDINE Geneva TECH 074506 CIMETIDINE Tablet; 300MG CIMETIDINE Geneva TECH 074506 CIMETIDINE Tablet; 400MG CIMETIDINE Geneva TECH 074506 CIMETIDINE Tablet; 800MG CIMETIDINE Geneva TECH 017920 CIMETIDINE Tablet; 200MG TAGAMET GLAXOSMITHKLINE 017920 CIMETIDINE Tablet; 300MG TAGAMET GLAXOSMITHKLINE 017920 CIMETIDINE Tablet; 400MG TAGAMET GLAXOSMITHKLINE 017920 CIMETIDINE Tablet; 800MG TAGAMET GLAXOSMITHKLINE 074401 CIMETIDINE Tablet; 200MG CIMETIDINE Ivax 074424 CIMETIDINE Tablet; 200MG CIMETIDINE Ivax 074424 CIMETIDINE Tablet; 300MG CIMETIDINE Ivax 074401 CIMETIDINE Tablet; 300MG CIMETIDINE Ivax 074401 CIMETIDINE Tablet; 400MG CIMETIDINE Ivax 074424 CIMETIDINE Tablet; 400MG CIMETIDINE Ivax 074424 CIMETIDINE Tablet; 800MG CIMETIDINE Ivax 074402 CIMETIDINE Tablet; 800MG CIMETIDINE Ivax 074250 CIMETIDINE Tablet; 300MG CIMETIDINE LEK 074250 CIMETIDINE Tablet; 400MG CIMETIDINE LEK 074250 CIMETIDINE Tablet; 800MG CIMETIDINE LEK 074246 CIMETIDINE Tablet; 200MG CIMETIDINE Mylan 074246 CIMETIDINE Tablet; 300MG CIMETIDINE Mylan 074246 CIMETIDINE Tablet; 400MG CIMETIDINE Mylan 074246 CIMETIDINE Tablet; 800MG CIMETIDINE Mylan 074568 CIMETIDINE Tablet; 200MG CIMETIDINE Pliva 074568 CIMETIDINE Tablet; 300MG CIMETIDINE Pliva 074568 CIMETIDINE Tablet; 400MG CIMETIDINE Pliva 074566 CIMETIDINE Tablet; 800MG CIMETIDINE Pliva 074151 CIMETIDINE Tablet; 200MG CIMETIDINE Teva 074365 CIMETIDINE Tablet; 200MG CIMETIDINE Teva 074365 CIMETIDINE Tablet; 300MG CIMETIDINE Teva 074151 CIMETIDINE Tablet; 300MG CIMETIDINE Teva 074151 CIMETIDINE Tablet; 400MG CIMETIDINE Teva 074365 CIMETIDINE Tablet; 400MG CIMETIDINE Teva 074365 CIMETIDINE Tablet; 800MG CIMETIDINE Teva 074463 CIMETIDINE Tablet; 800MG CIMETIDINE Teva 074890 CIMETIDINE Tablet; 200MG CIMETIDINE Torpharm 074890 CIMETIDINE Tablet; 300MG CIMETIDINE Torpharm 074890 CIMETIDINE Tablet; 400MG CIMETIDINE Torpharm 074890 CIMETIDINE Tablet; 800MG CIMETIDINE Torpharm 074349 CIMETIDINE Tablet; 200MG CIMETIDINE Watson 074349 CIMETIDINE Tablet; 300MG CIMETIDINE Watson 074349 CIMETIDINE Tablet; 400MG CIMETIDINE Watson 074316 CIMETIDINE Tablet; 800MG CIMETIDINE Watson 074468 CIMETIDINE HYDROCHLORIDE Injection 120MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074468 CIMETIDINE HYDROCHLORIDE Injection 180MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074468 CIMETIDINE HYDROCHLORIDE Injection 240MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074344 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Abbott 074345 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Abbott 074412 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Abbott 074422 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Abbott 074296 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Abbott 074468 CIMETIDINE HYDROCHLORIDE Injection 360MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074468 CIMETIDINE HYDROCHLORIDE Injection 480MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074269 CIMETIDINE HYDROCHLORIDE Injection 6MG BASE/ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074468 CIMETIDINE HYDROCHLORIDE Injection 90MG BASE/100ML CIMETIDINE HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Abbott 074428 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL CLONMEL 074005 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL ENDO 074252 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL Gensia Sicor 017939 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML TAGAMET GLAXOSMITHKLINE 019434 CIMETIDINE HYDROCHLORIDE Injection 6MG BASE/ML TAGAMET HCL IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GLAXOSMITHKLINE 074353 CIMETIDINE HYDROCHLORIDE Injection 300MG BASE/2ML CIMETIDINE HCL LUITPOLD 074176 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL ALPHARMA 074859 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL Copley 075110 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL DURAMED Barr 074251 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL ENDO 074664 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL HI TECH 074757 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL Morton Grove 075560 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL Novex 074553 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL ASSOC 074541 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL Roxane 074610 CIMETIDINE HYDROCHLORIDE Solution; 300MG BASE/5ML CIMETIDINE HCL Teva   For the latest approval information, locate this drug using this index.