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FDA Orange Book · active-ingredient family

Dextroamphetamine sulfate

Dextroamphetamine sulfate is approved as 1 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEXEDRINE SPANSULE · NDA 017078

1

Brand (NDA)

39

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
DEXEDRINE SPANSULERLD×3IMPAX LABS INCNDA 017078ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (39)

ProductApplicantApplicationTEApproved
DEXTROAMPHETAMINE SULFATE×2TRIS PHARMA INCANDA 206095—Aug 18, 2022
DEXTROAMPHETAMINE SULFATE×7WINDER LABS LLCANDA 212160AAJun 07, 2021
DEXTROAMPHETAMINE SULFATE×3STRIDES PHARMAANDA 205077—Jun 21, 2019
DEXTROAMPHETAMINE SULFATE×3STRIDES PHARMA INTLANDA 205673—Oct 31, 2017
DEXTROAMPHETAMINE SULFATE×2NUVO PHARMANDA 210059AAOct 18, 2017
DEXTROAMPHETAMINE SULFATE×3NESHER PHARMSANDA 209111—Jun 27, 2017
DEXTROAMPHETAMINE SULFATE×2NESHER PHARMSANDA 206588—Mar 28, 2016
DEXTROAMPHETAMINE SULFATE×2NOVEL LABS INCANDA 204330AAMar 16, 2016
DEXTROAMPHETAMINE SULFATE×3QUAGENANDA 206735—Jan 27, 2016
DEXTROAMPHETAMINE SULFATE×2AVANTHI INCANDA 203548AANov 23, 2015
DEXTROAMPHETAMINE SULFATE×2EPIC PHARMA LLCANDA 090652—Mar 07, 2014
DEXTROAMPHETAMINE SULFATE×2AUROLIFE PHARMA LLCANDA 202893AAJul 31, 2013
DEXTROAMPHETAMINE SULFATETRIS PHARMA INCANDA 203644AAMay 29, 2013
DEXTROAMPHETAMINE SULFATE×3ACTAVIS ELIZABETHANDA 203901ABNov 30, 2012
DEXTROAMPHETAMINE SULFATE×7AZURITYANDA 090533AAOct 25, 2011
DEXTROAMPHETAMINE SULFATEPRASCOANDA 040776AAJan 29, 2008
DEXTROAMPHETAMINE SULFATE×3ABLEANDA 076814—Aug 25, 2004
DEXTROAMPHETAMINE SULFATE×3SPECGX LLCANDA 076353ABMay 06, 2003
DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 040365—Oct 31, 2002
DEXTROAMPHETAMINE SULFATENESHER PHARMSANDA 040367—Oct 31, 2002
DEXTROAMPHETAMINE SULFATE×2SPECGX LLCANDA 040436AAJan 29, 2002
DEXTROAMPHETAMINE SULFATE×3SENORES PHARMSANDA 076137—Jan 18, 2002
DEXTROAMPHETAMINE SULFATE×2BARRANDA 040361AAJan 31, 2001
DEXTROAMPHETAMINE SULFATESTRIDES PHARMA INTLANDA 040299—May 13, 1999
DEXAMPEXTEVAANDA 085355—Approved Prior to Jan 1, 1982
DEXEDRINEGLAXOSMITHKLINEANDA 083902—Approved Prior to Jan 1, 1982
DEXAMPEX×2TEVAANDA 083735—Approved Prior to Jan 1, 1982
DEXEDRINERLDGLAXOSMITHKLINEANDA 084935—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEANI PHARMSANDA 085370—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEHALSEYANDA 083930—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATE×2LANNETTANDA 083903—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATELANNETTANDA 085652—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEMAST MMANDA 086521—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEPUREPAC PHARMANDA 084125—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATESANDOZANDA 085371—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEVITARINEANDA 084986—Approved Prior to Jan 1, 1982
DEXTROAMPHETAMINE SULFATEVITARINEANDA 085892—Approved Prior to Jan 1, 1982
DEXTROSTATRLD×2SHIREANDA 084051—Approved Prior to Jan 1, 1982
FERNDEXFERNDALE LABSANDA 084001—Approved Prior to Jan 1, 1982

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.

Dextroamphetamine sulfate — 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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