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 Prescription AB Yes Yes
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

DIAMOX

CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210423 ALEMBIC PHARMS LTD
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205301 CADILA
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090779 HERITAGE PHARMS INC
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204691 NOSTRUM LABS INC
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203434 NOVAST LABS
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 040904 ZYDUS PHARMS USA INC
DIAMOX ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 012945 TEVA BRANDED PHARM

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