Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086923
Company: PAR PHARM
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
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-33 Labeling

Label is not available on this site.

12/07/1999 SUPPL-32 Labeling

Label is not available on this site.

06/23/1997 SUPPL-31 Labeling

Label is not available on this site.

07/11/1996 SUPPL-30 Labeling

Label is not available on this site.

11/01/1991 SUPPL-29 Labeling

Label is not available on this site.

04/19/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/29/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/04/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/29/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/29/1983 SUPPL-12 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 VALEANT PHARMS NORTH
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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