FDA Orange Book · active-ingredient family
Butorphanol tartrate
Butorphanol tartrate: 2 brands, 14 generics; first approved Dec 12, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
14
Listed patents
0
Presentations
26
Brand (NDA) products
Originator applications
- STADOLRLDBRISTOL MYERS SQUIBBNDA 0198901991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/SPRAY SPRAY, METERED NASAL Discontinued — - STADOLRLDAPOTHECONNDA 017857—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- BUTORPHANOL TARTRATEHIKMA FARMACEUTICAANDA 07840020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - BUTORPHANOL TARTRATEHIKMA FARMACEUTICAANDA 0782472009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - BUTORPHANOL TARTRATEAPOTEXANDA 0754992002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/SPRAY SPRAY, METERED NASAL Rx AB - BUTORPHANOL TARTRATERSHIKMAANDA 0758242002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/SPRAY SPRAY, METERED NASAL Rx AB - BUTORPHANOL TARTRATEBAXTER HLTHCARE CORPANDA 0756972001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARE CORPANDA 07569520012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — - BUTORPHANOL TARTRATERISINGANDA 0757592001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/SPRAY SPRAY, METERED NASAL Discontinued — - BUTORPHANOL TARTRATEHOSPIRAANDA 07555920002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — - BUTORPHANOL TARTRATEHOSPIRAANDA 07534219992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07517019982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued — - BUTORPHANOL TARTRATEHIKMAANDA 0750461998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ML INJECTABLE INJECTION Rx AP - HIKMAANDA 07504519982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - HOSPIRAANDA 07462619972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP 2MG/ML INJECTABLE INJECTION Rx AP - HOSPIRAANDA 07462019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — 2MG/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
35 yr 2 mo ago
Most recent approval
17 yr 6 mo ago
Approvals span 1991–2009 across 16 FDA applications.
Brand (NDA) 213%
Generic (ANDA) 1488%
Butorphanol tartrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
