Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 015103
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMI-REGROTON CHLORTHALIDONE; RESERPINE 25MG;0.125MG TABLET;ORAL Discontinued None No No
REGROTON CHLORTHALIDONE; RESERPINE 50MG;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
05/08/1964 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
08/26/1988 SUPPL-38 Labeling

Label is not available on this site.

09/15/1987 SUPPL-37 Labeling

Label is not available on this site.

09/04/1986 SUPPL-36 Labeling

Label is not available on this site.

01/08/1985 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1983 SUPPL-34 Labeling

Label is not available on this site.

06/03/1983 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1977 SUPPL-32 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/07/1977 SUPPL-31 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/01/1977 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/12/1976 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1976 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/08/1976 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/08/1975 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1975 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1975 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

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