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Details for NDA: 075838

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

Summary for NDA: 075838


Summary for product number 001

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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