Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075289
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/27/2000 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075289.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/08/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/04/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/2001 SUPPL-1 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75289S1Ltr.pdf

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090649 MYLAN
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS USA INC
PROCARDIA XL NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 090649 MYLAN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210614 NOVAST LABS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 077127 OSMOTICA PHARM US
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 203126 TWI PHARMS
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 075289 VALEANT PHARMS NORTH
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210012 ZYDUS PHARMS USA INC
PROCARDIA XL NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019684 PFIZER

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English