Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086055
Company: HIKMA INTL PHARMS
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
11/02/1987 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
07/01/2002 SUPPL-43 Labeling

Label is not available on this site.

05/01/2001 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-41 Labeling

Label is not available on this site.

03/07/2001 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-38 Labeling

Label is not available on this site.

03/02/1994 SUPPL-37 Labeling

Label is not available on this site.

12/04/1992 SUPPL-36 Labeling

Label is not available on this site.

03/27/1991 SUPPL-35 Labeling

Label is not available on this site.

02/13/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-29 Labeling

Label is not available on this site.

06/16/1993 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/02/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/02/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/07/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/10/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/09/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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