Orange Book product · Brand (NDA)
PROCARDIA
NIFEDIPINE
At a glance
Jul 24, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 1986
40 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
NIFEDIPINE
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018482
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.
- 1993ADALAT CCBrand (NDA)
NDA 020198 · NORWICH
- 1989PROCARDIA XLBrand (NDA)
NDA 019684 · PFIZER
- 1985ADALATBrand (NDA)
NDA 019478 · BAYER PHARMS
- 2022NIFEDIPINEGeneric (ANDA)
ANDA 216896 · ALEMBIC
- 2022NIFEDIPINEGeneric (ANDA)
ANDA 216019 · PHARMADAX
- 2022NIFEDIPINEGeneric (ANDA)
ANDA 216067 · ALKEM LABS LTD
- 2021NIFEDIPINEGeneric (ANDA)
ANDA 213361 · AUROBINDO PHARMA
- 2020NIFEDIPINEGeneric (ANDA)
ANDA 212016 · ELITE PHARM SOLUTION
- 2019NIFEDIPINEGeneric (ANDA)
ANDA 210838 · SPIL
- 2019NIFEDIPINEGeneric (ANDA)
ANDA 210614 · NOVAST LABS
- 2018NIFEDIPINEGeneric (ANDA)
ANDA 210184 · ZYDUS PHARMS
- 2017NIFEDIPINEGeneric (ANDA)
ANDA 210012 · ZYDUS PHARMS
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.
