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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206964
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASPIRIN AND DIPYRIDAMOLE ASPIRIN; DIPYRIDAMOLE 25MG;200MG CAPSULE, EXTENDED RELEASE;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
01/18/2017 ORIG-1 Approval 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
04/16/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

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