Orange Book product · Brand (NDA)
PROCARDIA XL
NIFEDIPINE
At a glance
Sep 06, 1989
Approved
Brand (NDA)
Application
AB2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 06, 1989
37 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NIFEDIPINE
Strength
30MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB2
Application
NDA 019684
Product number
001
Marketing status
RX
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
- 1985ADALATBrand (NDA)
NDA 019478 · BAYER PHARMS
- —PROCARDIABrand (NDA)
NDA 018482 · PFIZER
- 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.
