FDA Orange Book · active-ingredient family
Cimetidine
Cimetidine is approved as 3 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TAGAMET HB · NDA 020238
3
Brand (NDA)
30
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAGAMET HBRLD×2 | MEDTECH PRODUCTS | NDA 020238 | — | Jun 19, 1995 | |
| TAGAMETRLD×4 | GLAXOSMITHKLINE | NDA 017920 | — | Approved Prior to Jan 1, 1982 | |
| TAGAMET HB 200 | GLAXOSMITHKLINE | NDA 020951 | — | Jul 09, 1999 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CIMETIDINE×4 | AUROBINDO PHARMA LTD | ANDA 218997 | AB | Nov 12, 2024 | |
| CIMETIDINE×4 | BIONPHARMA | ANDA 218220 | AB | Nov 07, 2024 | |
| CIMETIDINE | WATSON LABS TEVA | ANDA 075425 | — | Jul 29, 1999 | |
| CIMETIDINE | IVAX SUB TEVA PHARMS | ANDA 075345 | — | Jun 16, 1999 | |
| CIMETIDINE×4 | HIKMA | ANDA 074890 | — | Dec 18, 1998 | |
| CIMETIDINE | L PERRIGO CO | ANDA 075285 | — | Oct 29, 1998 | |
| CIMETIDINE×2 | APOTEX | ANDA 074948 | — | Jun 19, 1998 | |
| CIMETIDINE | CONTRACT PHARMACAL | ANDA 074961 | — | Jun 19, 1998 | |
| CIMETIDINE | CONTRACT PHARMACAL | ANDA 074963 | — | Jun 19, 1998 | |
| CIMETIDINE | PERRIGO | ANDA 074972 | — | Jun 19, 1998 | |
| CIMETIDINE×2 | SANDOZ | ANDA 075122 | — | Jun 19, 1998 | |
| CIMETIDINE×3 | PLIVA | ANDA 074568 | — | Feb 27, 1997 | |
| CIMETIDINE | PLIVA | ANDA 074566 | — | Feb 27, 1997 | |
| CIMETIDINE×3 | WATSON LABS INC | ANDA 074349 | — | Aug 30, 1996 | |
| CIMETIDINE | WATSON LABS INC | ANDA 074316 | — | Feb 28, 1996 | |
| CIMETIDINE×4 | UPSHER SMITH LABS | ANDA 074506 | — | Jan 24, 1996 | |
| CIMETIDINE×4 | IVAX SUB TEVA PHARMS | ANDA 074424 | — | Jul 28, 1995 | |
| CIMETIDINE×4 | SANDOZ | ANDA 074250 | — | Jun 29, 1995 | |
| CIMETIDINE×2 | NOVITIUM PHARMA | ANDA 074340 | — | Jun 23, 1995 | |
| CIMETIDINE | NOVITIUM PHARMA | ANDA 074339 | — | Jun 23, 1995 | |
| CIMETIDINE×3 | IVAX SUB TEVA PHARMS | ANDA 074401 | — | May 30, 1995 | |
| CIMETIDINE | IVAX SUB TEVA PHARMS | ANDA 074402 | — | May 30, 1995 | |
| CIMETIDINE×4 | TEVA | ANDA 074365 | — | Feb 28, 1995 | |
| CIMETIDINE×4 | CHARTWELL RX | ANDA 074100 | — | Jan 31, 1995 | |
| CIMETIDINE×2 | CYCLE | ANDA 074361 | — | Dec 23, 1994 | |
| CIMETIDINE | CYCLE | ANDA 074371 | — | Dec 23, 1994 | |
| CIMETIDINE×4 | CHARTWELL MOLECULES | ANDA 074329 | AB | May 17, 1994 | |
| CIMETIDINE×4 | MYLAN | ANDA 074246 | AB | May 17, 1994 | |
| CIMETIDINE×3 | TEVA | ANDA 074151 | AB | May 17, 1994 | |
| CIMETIDINE | TEVA | ANDA 074463 | AB | May 17, 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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
