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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009388
Company: TEVA WOMENS

Products on NDA 009388

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DIAMOX	ACETAZOLAMIDE SODIUM	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009388

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
05/13/2022	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008943s052,009388s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/008943Orig1s052; 009388Orig1s038ltr.pdf
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.

Labels for NDA 009388

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2022	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008943s052,009388s038lbl.pdf

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