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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012945
Company: TEVA BRANDED PHARM

Products on NDA 012945

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAMOX	ACETAZOLAMIDE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012945

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/25/1962	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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-47	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012945s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012945Orig1s047ltr.pdf
04/09/2014	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
03/19/2014	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
03/15/2005	SUPPL-38	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s038.pdf
03/15/2005	SUPPL-37	Manufacturing (CMC)	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s037.pdf
07/21/2003	SUPPL-34	Labeling		Label is not available on this site.
09/27/1999	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/1995	SUPPL-28	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 012945

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2022	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012945s047lbl.pdf
03/15/2005	SUPPL-38	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf
03/15/2005	SUPPL-37	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf

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