Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040371
Company: WATSON LABS

Products on ANDA 040371

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	500MG;7.5MG	TABLET;ORAL	Discontinued	None	No	No
OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	650MG;10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040371

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40371ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40-371_Oxycodone%20And%20Acetaminophe.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.