Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012164
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NATURETIN-10 BENDROFLUMETHIAZIDE 10MG TABLET;ORAL Discontinued None No No
NATURETIN-2.5 BENDROFLUMETHIAZIDE 2.5MG TABLET;ORAL Discontinued None No No
NATURETIN-5 BENDROFLUMETHIAZIDE 5MG 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
12/07/1959 ORIG-1 Approval Type 3 - New Dosage Form 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
09/02/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/01/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/11/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/04/1982 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/19/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/15/1981 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1989 SUPPL-20 Labeling

Label is not available on this site.

05/04/1979 SUPPL-19 Labeling

Label is not available on this site.

06/16/1977 SUPPL-18 Labeling

Label is not available on this site.

06/16/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1976 SUPPL-16 Labeling

Label is not available on this site.

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