Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012845
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENESE POLYTHIAZIDE 1MG TABLET;ORAL Discontinued None No No
RENESE POLYTHIAZIDE 2MG TABLET;ORAL Discontinued None No No
RENESE POLYTHIAZIDE 4MG 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
09/26/1961 ORIG-1 Approval Type 1 - New Molecular Entity 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
06/24/1998 SUPPL-26 Labeling

Label is not available on this site.

06/26/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/20/1984 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/1984 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/05/1981 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1978 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1977 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1976 SUPPL-17 Labeling

Label is not available on this site.

09/28/1976 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/28/1975 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1975 SUPPL-12 Labeling

Label is not available on this site.

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