Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086925
Company: PAR PHARM
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
03/12/1987 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
05/24/2002 SUPPL-37 Labeling

Label is not available on this site.

12/07/1999 SUPPL-36 Labeling

Label is not available on this site.

03/09/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-34 Labeling

Label is not available on this site.

07/11/1996 SUPPL-33 Labeling

Label is not available on this site.

11/01/1991 SUPPL-32 Labeling

Label is not available on this site.

03/16/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/16/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/04/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/29/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/27/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1982 SUPPL-10 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

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