Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086054
Company: HIKMA INTL PHARMS
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
10/29/1987 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-41 Labeling

Label is not available on this site.

04/03/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-39 Labeling

Label is not available on this site.

10/01/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-37 Labeling

Label is not available on this site.

07/06/1994 SUPPL-36 Labeling

Label is not available on this site.

12/04/1992 SUPPL-35 Labeling

Label is not available on this site.

03/27/1991 SUPPL-34 Labeling

Label is not available on this site.

02/13/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 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 Labeling

Label is not available on this site.

07/18/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-26 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

01/07/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/11/1984 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/10/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

07/23/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/10/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/10/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/10/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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