Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016776
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORBITRATE ISOSORBIDE DINITRATE 5MG TABLET, CHEWABLE;ORAL Discontinued None No No
SORBITRATE ISOSORBIDE DINITRATE 10MG TABLET, CHEWABLE;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
12/07/1970 ORIG-1 Approval Type 3 - New Dosage Form 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-36 Labeling

Label is not available on this site.

10/11/1996 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/01/1996 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/21/1982 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/28/1977 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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