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FDA Orange Book · active-ingredient family

Acetaminophen; propoxyphene napsylate

Acetaminophen; propoxyphene napsylate is approved as 1 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DARVOCET-N 100 · NDA 017122

1

Brand (NDA)

28

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
DARVOCET-N 100×2XANODYNE PHARMNDA 017122—Approved Prior to Jan 1, 1982

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMIRROR PHARMSANDA 077821—Feb 11, 2008
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN×2WOCKHARDT LTDANDA 077677—Mar 16, 2007
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENWATSON LABS FLORIDAANDA 077196—Jun 28, 2005
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENWATSON LABS FLORIDAANDA 076609—Nov 16, 2004
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENCORNERSTONEANDA 076750—Jun 28, 2004
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENCORNERSTONEANDA 076743—May 07, 2004
DARVOCET A500XANODYNE PHARMANDA 076429—Sep 10, 2003
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENABLEANDA 075838—Jul 11, 2001
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN×2VINTAGE PHARMSANDA 074843—Feb 15, 2001
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMALLINCKRODTANDA 075738—Feb 02, 2001
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTEVAANDA 074119—Dec 19, 1994
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENHALSEYANDA 072105—May 13, 1988
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENHALSEYANDA 072106—May 13, 1988
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMYLANANDA 072195—Feb 16, 1988
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENSUPERPHARMANDA 071319—Jan 06, 1987
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENACTAVIS ELIZABETHANDA 070910—Jan 02, 1987
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENWATSON LABSANDA 070398—Dec 18, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENWATSON LABSANDA 070399—Dec 18, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMUTUAL PHARMANDA 070615—Mar 21, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMUTUAL PHARMANDA 070771—Mar 21, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMUTUAL PHARMANDA 070775—Mar 21, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENSANDOZANDA 070443—Jan 23, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTEVAANDA 070732—Jan 03, 1986
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENIVAX SUB TEVA PHARMSANDA 070146—Aug 02, 1985
PROPACET 100TEVAANDA 070107—Jun 12, 1985
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMUTUAL PHARMANDA 070115—Jun 12, 1985
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMUTUAL PHARMANDA 070116—Jun 12, 1985
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENMYLAN PHARMS INCANDA 070145—Jun 12, 1985

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Acetaminophen; propoxyphene napsylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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