Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009388
Company: TEVA WOMENS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAMOX ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/25/1954 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
11/26/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1999 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/01/1994 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1994 SUPPL-30 Labeling

Label is not available on this site.

12/09/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1990 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1990 SUPPL-25 Labeling

Label is not available on this site.

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