Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088882
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;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
10/22/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1991 SUPPL-9 Labeling

Label is not available on this site.

01/28/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/15/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/15/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/15/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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