Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012945
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAMOX ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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