FDA Orange Book · active-ingredient family
Atracurium besylate
Atracurium besylate: 1 brand, 22 generics; first approved Nov 23, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
22
Listed patents
0
Presentations
24
Brand (NDA) products
Originator applications
- TRACRIUMRLDHOSPIRANDA 01883119852 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 10MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- ATRACURIUM BESYLATEPHARMOBEDIENTANDA 2060962017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - PHARMOBEDIENTANDA 2060012017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEEUGIA PHARMAANDA 2060112015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - EUGIA PHARMAANDA 2060102015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEHOSPIRA INCANDA 0907612012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HOSPIRA INCANDA 0907822012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ATRACURIUM BESYLATEMEITHEALANDA 0914892012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - MEITHEALANDA 0914882012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ATRACURIUM BESYLATEWATSON PHARMS TEVAANDA 0749451998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - WATSON LABS INCANDA 0749441998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEBAXTER HLTHCAREANDA 0748241997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 0748251997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATERSHIKMAANDA 0749011997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HIKMAANDA 0749001997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - ATRACURIUM BESYLATETEVA PARENTERALANDA 0747841997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEHOSPIRAANDA 0747401997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0747411997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0746391997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEBAXTER HLTHCARE CORPANDA 0747531997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARE CORPANDA 0747681997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - ATRACURIUM BESYLATEHOSPIRAANDA 0746321996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0746331996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/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
43 yr 4 mo ago
Most recent approval
9 yr 3 mo ago
Approvals span 1983–2017 across 23 FDA applications.
Brand (NDA) 14%
Generic (ANDA) 2296%
Atracurium besylate: 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.
