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FDA Orange Book · active-ingredient family

Tramadol hydrochloride

Tramadol hydrochloride is approved as 6 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:QDOLO · NDA 214044

6

Brand (NDA)

34

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, solution, tablet, tablet, extended release, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
QDOLORLDROSEMONTNDA 214044—Sep 01, 2020
CONZIPRLD×4CIPHER PHARMS INCNDA 022370—May 07, 2010
RYZOLTRLD×3PURDUE PHARMANDA 021745—Dec 30, 2008
ULTRAM ERRLD×3VALEANT PHARMSNDA 021692—Sep 08, 2005
ULTRAMRLD×2JANSSEN PHARMSNDA 020281—Mar 03, 1995
RYBIX ODTSHIONOGI INCNDA 021693—May 05, 2005

Generic (ANDA) products (34)

ProductApplicantApplicationTEApproved
TRAMADOL HYDROCHLORIDE×2STRIDES PHARMAANDA 202075ABMar 23, 2026
TRAMADOL HYDROCHLORIDE×3MACLEODS PHARMS LTDANDA 209404AB1Jan 31, 2025
TRAMADOL HYDROCHLORIDE×4RUBICON RESEARCHANDA 208708ABNov 27, 2023
TRAMADOL HYDROCHLORIDEUNICHEMANDA 211825ABAug 09, 2019
TRAMADOL HYDROCHLORIDEPURACAP LABS BLUANDA 206706—Jul 02, 2019
TRAMADOL HYDROCHLORIDE×3MYLANANDA 205257—Dec 22, 2015
TRAMADOL HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 204421—Oct 20, 2015
TRAMADOL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 205702—Sep 25, 2015
TRAMADOL HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 203494ABMar 31, 2014
TRAMADOL HYDROCHLORIDEACCORD HLTHCAREANDA 202390—May 16, 2013
TRAMADOL HYDROCHLORIDECSPC OUYI PHARM COANDA 091498ABMar 29, 2013
TRAMADOL HYDROCHLORIDEIPCA LABS LTDANDA 201973—Nov 16, 2012
TRAMADOL HYDROCHLORIDE×3ACTAVIS ELIZABETHANDA 091609—Jun 27, 2012
TRAMADOL HYDROCHLORIDE×3PH HEALTHANDA 200491—Jun 27, 2012
TRAMADOL HYDROCHLORIDE×3SUN PHARMANDA 091607—Dec 30, 2011
TRAMADOL HYDROCHLORIDE×3SUN PHARMANDA 201384—Dec 07, 2011
TRAMADOL HYDROCHLORIDE×3LUPIN LTDANDA 200503AB1Aug 29, 2011
TRAMADOL HYDROCHLORIDESENORES PHARMSANDA 090404ABJan 31, 2011
TRAMADOL HYDROCHLORIDENORTHSTAR HLTHCAREANDA 078935—May 26, 2010
TRAMADOL HYDROCHLORIDE×3STRIDES PHARMA INTLANDA 078783—Nov 13, 2009
TRAMADOL HYDROCHLORIDEMYLAN PHARMS INCANDA 075980—Nov 21, 2002
TRAMADOL HYDROCHLORIDEASTAANDA 075974—Jul 12, 2002
TRAMADOL HYDROCHLORIDEAPOTEXANDA 075981—Jul 10, 2002
TRAMADOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 075963—Jul 03, 2002
TRAMADOL HYDROCHLORIDEPLIVAANDA 075982—Jul 01, 2002
TRAMADOL HYDROCHLORIDE×2GRAVITI PHARMSANDA 075968ABJun 25, 2002
TRAMADOL HYDROCHLORIDESPECGX LLCANDA 075983—Jun 25, 2002
TRAMADOL HYDROCHLORIDEWATSON LABSANDA 075962—Jun 24, 2002
TRAMADOL HYDROCHLORIDEMYLANANDA 075986—Jun 21, 2002
TRAMADOL HYDROCHLORIDEAMNEAL PHARMSANDA 076003ABJun 20, 2002
TRAMADOL HYDROCHLORIDESUN PHARM INDUSTRIESANDA 076100—Jun 20, 2002
TRAMADOL HYDROCHLORIDEACTAVIS ELIZABETHANDA 075960—Jun 19, 2002
TRAMADOL HYDROCHLORIDESUN PHARM INDS INCANDA 075964ABJun 19, 2002
TRAMADOL HYDROCHLORIDETEVAANDA 075977ABJun 19, 2002

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11103452Sep 01, 2040in 14 yr 5 mo
ProductU-3197
11752103Sep 01, 2040in 14 yr 5 mo
ProductU-3197

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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