Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075851
Company: MYLAN

Products on ANDA 075851

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075851

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75851ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2003	SUPPL-2	Labeling		Label is not available on this site.
03/13/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075851

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/17/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf