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FDA Orange Book · active-ingredient family

Butorphanol tartrate

Butorphanol tartrate is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:STADOL · NDA 019890

2

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, spray, metered

ProductApplicantApplicationTEApproved
STADOLRLDBRISTOL MYERS SQUIBBNDA 019890—Dec 12, 1991
STADOLRLD×3APOTHECONNDA 017857—Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
BUTORPHANOL TARTRATE×2HIKMA FARMACEUTICAANDA 078400APMay 01, 2009
BUTORPHANOL TARTRATEHIKMA FARMACEUTICAANDA 078247—Apr 29, 2009
BUTORPHANOL TARTRATEAPOTEXANDA 075499ABDec 04, 2002
BUTORPHANOL TARTRATEHIKMAANDA 075824ABMar 12, 2002
BUTORPHANOL TARTRATEBAXTER HLTHCARE CORPANDA 075697—Oct 23, 2001
BUTORPHANOL TARTRATE PRESERVATIVE FREE×2BAXTER HLTHCARE CORPANDA 075695—Oct 23, 2001
BUTORPHANOL TARTRATERISINGANDA 075759—Aug 08, 2001
BUTORPHANOL TARTRATE×2HOSPIRAANDA 075559—Mar 20, 2000
BUTORPHANOL TARTRATE×2HOSPIRAANDA 075342—Nov 04, 1999
BUTORPHANOL TARTRATE PRESERVATIVE FREE×2HOSPIRAANDA 075170—Sep 28, 1998
BUTORPHANOL TARTRATEHIKMAANDA 075046APAug 12, 1998
BUTORPHANOL TARTRATE PRESERVATIVE FREE×2HIKMAANDA 075045APAug 12, 1998
BUTORPHANOL TARTRATE PRESERVATIVE FREE×2HOSPIRAANDA 074626APJan 23, 1997
BUTORPHANOL TARTRATE PRESERVATIVE FREE×2HOSPIRAANDA 074620—Jan 22, 1997

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.

Butorphanol tartrate — 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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