FDA Orange Book · active-ingredient family
Cimetidine hydrochloride
Cimetidine hydrochloride is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · NDA 019434
3
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD | GLAXOSMITHKLINE | NDA 019434 | — | Oct 31, 1985 | |
| TAGAMET | GLAXOSMITHKLINE | NDA 017939 | — | Approved Prior to Jan 1, 1982 | |
| TAGAMET | GLAXOSMITHKLINE | NDA 017924 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CIMETIDINE HYDROCHLORIDE | PHARM ASSOC | ANDA 075560 | — | Mar 15, 2000 | |
| CIMETIDINE HYDROCHLORIDE | ANI PHARMS | ANDA 074859 | — | Jul 09, 1998 | |
| CIMETIDINE HYDROCHLORIDE | ANI PHARMS | ANDA 075110 | — | Jun 18, 1998 | |
| CIMETIDINE HYDROCHLORIDE | TEVA PARENTERAL | ANDA 074252 | — | Nov 26, 1997 | |
| CIMETIDINE HYDROCHLORIDE | PAI HOLDINGS PHARM | ANDA 074664 | AA | Oct 28, 1997 | |
| CIMETIDINE HYDROCHLORIDE | PHARMOBEDIENT CNSLTG | ANDA 074757 | — | Oct 17, 1997 | |
| CIMETIDINE HYDROCHLORIDE | CYCLE | ANDA 074541 | — | Aug 05, 1997 | |
| CIMETIDINE HYDROCHLORIDE | HOSPIRA | ANDA 074296 | — | Mar 28, 1997 | |
| CIMETIDINE HYDROCHLORIDE | HOSPIRA | ANDA 074412 | — | Mar 28, 1997 | |
| CIMETIDINE HYDROCHLORIDE | PHARM ASSOC | ANDA 074553 | — | Jan 27, 1997 | |
| CIMETIDINE HYDROCHLORIDE | ANI PHARMS | ANDA 074610 | — | Sep 26, 1996 | |
| CIMETIDINE HYDROCHLORIDE | PH HEALTH | ANDA 074428 | — | Apr 25, 1996 | |
| CIMETIDINE HYDROCHLORIDE | HOSPIRA | ANDA 074344 | — | Jan 31, 1995 | |
| CIMETIDINE HYDROCHLORIDE | HOSPIRA | ANDA 074345 | — | Jan 31, 1995 | |
| CIMETIDINE HYDROCHLORIDE | HOSPIRA | ANDA 074422 | — | Jan 31, 1995 | |
| CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×6 | HOSPIRA | ANDA 074468 | — | Dec 29, 1994 | |
| CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HOSPIRA | ANDA 074269 | — | Dec 27, 1994 | |
| CIMETIDINE HYDROCHLORIDE | CHARTWELL MOLECULAR | ANDA 074251 | AA | Dec 22, 1994 | |
| CIMETIDINE HYDROCHLORIDE | LUITPOLD | ANDA 074353 | — | Dec 20, 1994 | |
| CIMETIDINE HYDROCHLORIDE | PH HEALTH | ANDA 074005 | — | Aug 31, 1994 | |
| CIMETIDINE HYDROCHLORIDE | G AND W LABS INC | ANDA 074176 | — | Jun 01, 1994 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Cimetidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
