Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016192
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORBITRATE ISOSORBIDE DINITRATE 5MG TABLET;ORAL Discontinued None No No
SORBITRATE ISOSORBIDE DINITRATE 10MG TABLET;ORAL Discontinued None 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
01/16/1968 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/1999 SUPPL-43 Labeling

Label is not available on this site.

10/11/1996 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/01/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/09/1981 SUPPL-25 Labeling

Label is not available on this site.

08/05/1980 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

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