Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074843
Company: VINTAGE PHARMS

Products on ANDA 074843

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	650MG;100MG	TABLET;ORAL	Discontinued	None	No	No
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE	325MG;50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074843

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2001	SUPPL-5	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf
02/15/2001	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf
02/15/2001	SUPPL-2	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf
02/15/2001	SUPPL-1	Manufacturing (CMC)-New Strength	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74843S1,2,3,5ltr.pdf