Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013621
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERTOFRANE DESIPRAMINE HYDROCHLORIDE 25MG CAPSULE;ORAL Discontinued None No No
PERTOFRANE DESIPRAMINE HYDROCHLORIDE 50MG CAPSULE;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
04/10/1968 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
07/30/1985 SUPPL-28 Labeling

Label is not available on this site.

05/01/1984 SUPPL-27 Labeling

Label is not available on this site.

07/13/1977 SUPPL-25 Labeling

Label is not available on this site.

08/16/1977 SUPPL-23 Labeling

Label is not available on this site.

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