Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011793
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESIDRIX HYDROCHLOROTHIAZIDE 25MG TABLET;ORAL Discontinued None No No
ESIDRIX HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Discontinued None No No
ESIDRIX HYDROCHLOROTHIAZIDE 100MG 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
02/12/1959 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
04/29/2002 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-69 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1997 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1996 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1996 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

07/31/1995 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1994 SUPPL-64 Labeling

Label is not available on this site.

03/10/1993 SUPPL-62 Labeling

Label is not available on this site.

06/05/1991 SUPPL-61 Labeling

Label is not available on this site.

07/30/1992 SUPPL-60 Labeling

Label is not available on this site.

11/09/1990 SUPPL-59 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/23/1988 SUPPL-58 Labeling

Label is not available on this site.

10/02/1986 SUPPL-57 Labeling

Label is not available on this site.

03/19/1985 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1982 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1982 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1982 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1986 SUPPL-51 Labeling

Label is not available on this site.

02/02/1981 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1980 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1980 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1979 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1979 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1979 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/1978 SUPPL-44 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/16/1977 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1977 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1978 SUPPL-41 Labeling

Label is not available on this site.

02/09/1977 SUPPL-40 Labeling

Label is not available on this site.

08/31/1976 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1977 SUPPL-38 Labeling

Label is not available on this site.

08/18/1976 SUPPL-37 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/20/1976 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/24/1976 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/09/1975 SUPPL-34 Labeling

Label is not available on this site.

03/24/1976 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1975 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1975 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/02/1975 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

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