Orange Book product · Brand (NDA)
CAPOTEN
CAPTOPRIL
At a glance
Jan 17, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 17, 1985
42 yr ago
Today
Pharmaceutical detail
Active ingredient
CAPTOPRIL
Strength
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018343
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023CAPTOPRILGeneric (ANDA)
ANDA 214442 · AIPING PHARM INC
- 2019CAPTOPRILGeneric (ANDA)
ANDA 212809 · AJANTA PHARMA LTD
- 2019CAPTOPRILGeneric (ANDA)
ANDA 212223 · SETON PHARMS
- 1998CAPTOPRILGeneric (ANDA)
ANDA 074737 · COREPHARMA
- 1997CAPTOPRILGeneric (ANDA)
ANDA 074677 · ANDAS 5 HOLDING
- 1997CAPTOPRILGeneric (ANDA)
ANDA 074748 · EGIS PHARMS
- 1997CAPTOPRILGeneric (ANDA)
ANDA 074640 · PUREPAC PHARM
- 1997CAPTOPRILGeneric (ANDA)
ANDA 074532 · WOCKHARDT BIO AG
- 1996CAPTOPRILGeneric (ANDA)
ANDA 074590 · G AND W LABS INC
- 1996CAPTOPRILGeneric (ANDA)
ANDA 074386 · WATSON LABS
- 1996CAPTOPRILGeneric (ANDA)
ANDA 074576 · WATSON LABS
- 1996CAPTOPRILGeneric (ANDA)
ANDA 074434 · AUROBINDO PHARMA USA
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.
