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Generated: March 23, 2019

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Details for New Drug Application (NDA): 070398

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NDA 070398 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-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.
Summary for 070398

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Dec 18, 1986TE:RLD:No

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