FDA Orange Book · active-ingredient family
Captopril
Captopril is approved as 1 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAPOTEN · NDA 018343
1
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAPOTENRLD×7 | AARXION ANDA HLDING | NDA 018343 | — | Jan 17, 1985 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAPTOPRIL×4 | AIPING PHARM INC | ANDA 214442 | AB | Jan 27, 2023 | |
| CAPTOPRIL×4 | AJANTA PHARMA LTD | ANDA 212809 | AB | Dec 13, 2019 | |
| CAPTOPRIL×4 | SETON PHARMS | ANDA 212223 | — | Oct 30, 2019 | |
| CAPTOPRIL×4 | COREPHARMA | ANDA 074737 | AB | Oct 28, 1998 | |
| CAPTOPRIL×4 | ANDAS 5 HOLDING | ANDA 074677 | AB | May 30, 1997 | |
| CAPTOPRIL×4 | EGIS PHARMS | ANDA 074748 | — | May 29, 1997 | |
| CAPTOPRIL×4 | PUREPAC PHARM | ANDA 074640 | — | Mar 31, 1997 | |
| CAPTOPRIL×4 | WOCKHARDT BIO AG | ANDA 074532 | AB | Mar 28, 1997 | |
| CAPTOPRIL×4 | G AND W LABS INC | ANDA 074590 | — | Aug 30, 1996 | |
| CAPTOPRIL×4 | WATSON LABS | ANDA 074386 | — | May 23, 1996 | |
| CAPTOPRIL×4 | WATSON LABS | ANDA 074576 | — | Apr 23, 1996 | |
| CAPTOPRIL×4 | AUROBINDO PHARMA USA | ANDA 074434 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | CHARTWELL RX | ANDA 074519 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | COSETTE PHARMS NC | ANDA 074433 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | COSETTE PHARMS NC | ANDA 074462 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | COSETTE PHARMS NC | ANDA 074483 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | DAVA PHARMS INC | ANDA 074423 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | HIKMA INTL PHARMS | ANDA 074505 | AB | Feb 13, 1996 | |
| CAPTOPRIL×4 | OXFORD PHARMS | ANDA 074418 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | PRINSTON INC | ANDA 074477 | AB | Feb 13, 1996 | |
| CAPTOPRIL×4 | SANDOZ | ANDA 074481 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | STRIDES PHARMA INTL | ANDA 074493 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | TEVA | ANDA 074322 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | WATSON LABS | ANDA 074451 | — | Feb 13, 1996 | |
| CAPTOPRIL×4 | CHARTWELL RX | ANDA 074363 | — | Nov 09, 1995 | |
| CAPTOPRIL×4 | APOTHECON | ANDA 074472 | — | Mar 31, 1995 |
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.
Captopril — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
