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FDA Orange Book · active-ingredient family

Acetaminophen; tramadol hydrochloride

Acetaminophen; tramadol hydrochloride is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ULTRACET · NDA 021123

1

Brand (NDA)

11

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ULTRACETRLDJANSSEN PHARMSNDA 021123—Aug 15, 2001

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMACLEODS PHARMS LTDANDA 206885—May 02, 2017
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAUROBINDO PHARMAANDA 207152ABMar 22, 2017
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMPP PHARMAANDA 078778—Apr 07, 2014
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENMICRO LABS LTD INDIAANDA 201952ABDec 14, 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENZYDUS PHARMS USA INCANDA 090460ABSep 06, 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENALKEM LABS LTDANDA 202076ABMar 30, 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENAMNEAL PHARMSANDA 090485ABDec 09, 2009
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENRISINGANDA 077858ABSep 26, 2008
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENGRAVITI PHARMSANDA 076914—Jul 26, 2006
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSUN PHARM INDS INCANDA 077184—Dec 16, 2005
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENCHARTWELL RXANDA 076475—Apr 21, 2005

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; tramadol hydrochloride — 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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