Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086034
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG 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
01/06/1988 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
12/10/1996 SUPPL-35 Labeling

Label is not available on this site.

02/17/1994 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

11/16/1992 SUPPL-33 Labeling

Label is not available on this site.

04/02/1992 SUPPL-32 Labeling

Label is not available on this site.

12/19/1991 SUPPL-31 Labeling

Label is not available on this site.

09/12/1991 SUPPL-30 Labeling

Label is not available on this site.

11/19/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/13/1988 SUPPL-26 Labeling

Label is not available on this site.

03/29/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/29/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/17/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/25/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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