|
|
|
 |
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 | Tagamet HB (cimitidine) Tablets, GlaxoSmithKline, Labeling Revision | Tagamet (cimetidine hydrochloride) Tablet, SmithKline Beecham, Labeling Revision | Tagamet HB 200 (cimetidine) tablets, GlaxoSmithKline, Manufacturing Change | Tagamet HB 200 (cimetidine) Tablets, GlaxoSmithKline, Labeling Revision
|