Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086222
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG 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
02/19/1988 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
03/20/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/21/1991 SUPPL-29 Labeling

Label is not available on this site.

02/06/1990 SUPPL-28 Labeling

Label is not available on this site.

11/03/1989 SUPPL-27 Labeling

Label is not available on this site.

06/13/1989 SUPPL-26 Labeling

Label is not available on this site.

05/08/1987 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

05/08/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/08/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/14/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/17/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/09/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/17/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/28/1983 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/28/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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