Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080521
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 300MG 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
02/28/1972 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
04/03/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/18/1997 SUPPL-42 Labeling

Label is not available on this site.

01/26/1993 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/01/1992 SUPPL-40 Labeling

Label is not available on this site.

11/19/1990 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

12/23/1991 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

12/23/1991 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/25/1983 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

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