Orange Book product · Brand (NDA)
ALTACE
RAMIPRIL
At a glance
Feb 27, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2007
19 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
RAMIPRIL
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 022021
Product number
001
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.
- 2025VOSTALLYBrand (NDA)
NDA 219757 · ROSEMONT PHARMS
- 1991ALTACEBrand (NDA)
NDA 019901 · KING PHARMS LLC
- 2015RAMIPRILGeneric (ANDA)
ANDA 091069 · APOTEX
- 2014RAMIPRILGeneric (ANDA)
ANDA 202392 · ACCORD HLTHCARE
- 2011RAMIPRILGeneric (ANDA)
ANDA 090650 · NATCO PHARMA
- 2011RAMIPRILGeneric (ANDA)
ANDA 091604 · AUROBINDO PHARMA LTD
- 2009RAMIPRILGeneric (ANDA)
ANDA 090697 · ZYDUS PHARMS USA INC
- 2009RAMIPRILGeneric (ANDA)
ANDA 078849 · RANBAXY LABS LTD
- 2008RAMIPRILGeneric (ANDA)
ANDA 078832 · ZYDUS PHARMS USA
- 2008RAMIPRILGeneric (ANDA)
ANDA 077004 · CIPLA
- 2008RAMIPRILGeneric (ANDA)
ANDA 079116 · COREPHARMA
- 2008RAMIPRILGeneric (ANDA)
ANDA 077513 · ACTAVIS ELIZABETH
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.
