Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086067
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG 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
10/26/1987 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-46 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-45 Labeling-Container/Carton Labels

Label is not available on this site.

09/26/2016 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

07/05/2002 SUPPL-38 Labeling

Label is not available on this site.

04/11/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2000 SUPPL-36 Labeling

Label is not available on this site.

03/07/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/2001 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/01/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/03/1997 SUPPL-32 Labeling

Label is not available on this site.

04/12/1994 SUPPL-31 Labeling

Label is not available on this site.

04/12/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/04/1992 SUPPL-29 Labeling

Label is not available on this site.

05/13/1991 SUPPL-28 Labeling

Label is not available on this site.

02/13/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-22 Labeling

Label is not available on this site.

06/16/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-20 Labeling

Label is not available on this site.

05/15/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/15/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/11/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/10/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/28/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

ISOSORBIDE DINITRATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISORDIL ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription Yes AB 012093 BAUSCH
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086067 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086923 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Prescription No AB 086221 SANDOZ

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