Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009838
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESERPINE RESERPINE 0.1MG TABLET;ORAL Discontinued None Yes No
RESERPINE RESERPINE 0.25MG TABLET;ORAL Discontinued None Yes 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
03/24/1955 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
06/17/2015 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

12/08/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/07/1999 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1996 SUPPL-33 Labeling

Label is not available on this site.

03/15/1996 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

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