Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084204
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 2.5MG 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
12/01/1978 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
12/01/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/16/1992 SUPPL-35 Labeling

Label is not available on this site.

04/03/1992 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/19/1991 SUPPL-31 Labeling

Label is not available on this site.

07/25/1990 SUPPL-30 Labeling

Label is not available on this site.

03/25/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/17/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/13/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/08/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/24/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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