Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008943
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAMOX ACETAZOLAMIDE 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DIAMOX ACETAZOLAMIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
07/27/1953 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/1999 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1991 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1990 SUPPL-46 Labeling

Label is not available on this site.

04/23/1990 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1990 SUPPL-44 Labeling

Label is not available on this site.

12/06/1989 SUPPL-43 Labeling

Label is not available on this site.

07/21/1988 SUPPL-42 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/22/1988 SUPPL-41 Labeling

Label is not available on this site.

08/11/1987 SUPPL-40 Labeling

Label is not available on this site.

06/16/1987 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1987 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1987 SUPPL-37 Labeling

Label is not available on this site.

03/21/1986 SUPPL-36 Labeling

Label is not available on this site.

05/13/1985 SUPPL-35 Labeling

Label is not available on this site.

09/25/1984 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1984 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/29/1982 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1982 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1981 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1980 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1980 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1980 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1979 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/14/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1979 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1978 SUPPL-23 Labeling

Label is not available on this site.

04/07/1978 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1978 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/09/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1977 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1977 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/06/1977 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/28/1977 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/28/1977 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

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