Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086223
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG 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
01/07/1988 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
02/21/2008 SUPPL-45 Labeling

Label is not available on this site.

06/07/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1999 SUPPL-40 Labeling

Label is not available on this site.

05/05/1999 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/25/1999 SUPPL-36 Labeling

Label is not available on this site.

03/25/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-33 Labeling

Label is not available on this site.

02/27/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/20/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/21/1991 SUPPL-30 Labeling

Label is not available on this site.

11/03/1989 SUPPL-29 Labeling

Label is not available on this site.

06/13/1989 SUPPL-28 Labeling

Label is not available on this site.

12/15/1983 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/28/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/28/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/25/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ISOSORBIDE DINITRATE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086066 HIKMA INTL PHARMS
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086925 PAR PHARM
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 086223 SANDOZ
ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Prescription No AB 213057 ZYDUS

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