Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086033
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;SUBLINGUAL Discontinued None No No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
02/26/1988 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-30 Labeling

Label is not available on this site.

08/25/1992 SUPPL-29 Labeling

Label is not available on this site.

04/02/1992 SUPPL-28 Labeling

Label is not available on this site.

09/12/1991 SUPPL-27 Labeling

Label is not available on this site.

11/19/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/13/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/13/1988 SUPPL-20 Labeling

Label is not available on this site.

06/17/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/25/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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