Orange Book product · Generic (ANDA)
NIFEDIPINE
NIFEDIPINE
At a glance
Nov 18, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 2022
3 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
NIFEDIPINE
Strength
30MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 216019
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NIFEDIPINE
- 1993ADALAT CCBrand (NDA)
NDA 020198 · NORWICH
- 1989PROCARDIA XLBrand (NDA)
NDA 019684 · PFIZER
- 1985ADALATBrand (NDA)
NDA 019478 · BAYER PHARMS
- —PROCARDIABrand (NDA)
NDA 018482 · PFIZER
- 2022NIFEDIPINEGeneric (ANDA)
ANDA 216896 · ALEMBIC
- 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.
