Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013636
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENESE-R POLYTHIAZIDE; RESERPINE 2MG;0.25MG 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
10/15/1963 ORIG-1 Approval Type 4 - New Combination 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
06/26/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/21/1984 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1984 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1983 SUPPL-16 Labeling

Label is not available on this site.

02/13/1981 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/22/1975 SUPPL-7 Labeling

Label is not available on this site.

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