Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088088
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription AB 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
01/04/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-33 Labeling-Container/Carton Labels

Label is not available on this site.

03/30/2007 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/2002 SUPPL-26 Labeling

Label is not available on this site.

04/11/2001 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2000 SUPPL-24 Labeling

Label is not available on this site.

03/07/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/17/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-20 Labeling

Label is not available on this site.

04/12/1994 SUPPL-19 Labeling

Label is not available on this site.

04/12/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/04/1992 SUPPL-17 Labeling

Label is not available on this site.

05/13/1991 SUPPL-16 Labeling

Label is not available on this site.

02/09/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/09/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

06/16/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-9 Labeling

Label is not available on this site.

10/14/1988 SUPPL-8 Labeling

Label is not available on this site.

05/11/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/10/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ISOSORBIDE DINITRATE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 088088 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 087537 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 20MG TABLET;ORAL Prescription No AB 089367 SANDOZ

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