Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075659
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFEDITAB CR NIFEDIPINE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
10/26/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75659TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2005 SUPPL-8 Labeling

Label is not available on this site.

06/18/2002 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

03/15/2002 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

04/05/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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