Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075128
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFEDITAB CR NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription AB1 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
03/10/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75128ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75128ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075128.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2005 SUPPL-11 Labeling

Label is not available on this site.

12/30/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2002 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/17/2002 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

07/23/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

AFEDITAB CR

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADALAT CC NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB1 020198 ALVOGEN
AFEDITAB CR NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075128 WATSON LABS TEVA
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201071 MYLAN
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 202987 NOVAST LABS LTD
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 077899 PAR PHARM
NIFEDIPINE NIFEDIPINE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 075269 VALEANT PHARMS NORTH

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