Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071893
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETOHEXAMIDE ACETOHEXAMIDE 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
11/25/1987 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
10/30/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/09/1991 SUPPL-7 Labeling

Label is not available on this site.

02/27/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/27/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/27/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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