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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040341
Company: VINTAGE PHARMS LLC

Products on ANDA 040341

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40341ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-341_Oxycodone%20And%20Acetaminophen.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf
07/31/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
10/18/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
05/18/2000	SUPPL-6	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/18/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
01/11/2000	SUPPL-4	Labeling		Label is not available on this site.
11/02/1999	SUPPL-3	Labeling		Label is not available on this site.
05/18/2000	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/18/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 040341

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2006	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf

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