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Details for New Drug Application (NDA): 075838

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NDA 075838 describes PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, which is a drug marketed by Halsey, Watson Labs Florida, Actavis Elizabeth, Mutual Pharm, Superpharm, Teva, Mirror Pharms, Able, Mallinckrodt, Cornerstone, Sandoz, Vintage Pharms, Mylan Pharms Inc, Ivax Sub Teva Pharms, Wockhardt Ltd, Mylan, and Watson Labs, and is included in twenty-six NDAs. It is available from eight suppliers. Additional details are available on the PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN profile page.

The generic ingredient in PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN is acetaminophen; propoxyphene napsylate. There are sixty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.

Summary for NDA: 075838

acetaminophen; propoxyphene napsylate
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;100MG
Approval Date:Jul 11, 2001TE:RLD:No

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