Orange Book product · Brand (NDA)
MONOPRIL
FOSINOPRIL SODIUM
At a glance
May 16, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 16, 1991
35 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSINOPRIL SODIUM
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019915
Product number
002
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.
- 2016FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 205670 · PRINSTON INC
- 2011FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 091163 · AUROBINDO PHARMA LTD
- 2006FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 077531 · WATSON LABS
- 2005FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076906 · APOTEX
- 2005FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 077222 · INVAGEN PHARMS
- 2004FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076987 · WATSON LABS
- 2004FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076620 · ACTAVIS LABS FL INC
- 2004FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076188 · UPSHER SMITH LABS
- 2004FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076483 · CHARTWELL RX
- 2004FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076580 · RANBAXY LABS LTD
- 2003FOSINOPRIL SODIUMGeneric (ANDA)
ANDA 076139 · TEVA
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.
