Orange Book product · Generic (ANDA)
BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE
At a glance
Apr 29, 2009
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2009
17 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTORPHANOL TARTRATE
Strength
2MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 078247
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BUTORPHANOL TARTRATE
- 1991STADOLBrand (NDA)
NDA 019890 · BRISTOL MYERS SQUIBB
- —STADOLBrand (NDA)
NDA 017857 · APOTHECON
- 2009BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 078400 · HIKMA FARMACEUTICA
- 2002BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075499 · APOTEX
- 2002BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075824 · HIKMA
- 2001BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075697 · BAXTER HLTHCARE CORP
- 2001BUTORPHANOL TARTRATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 075695 · BAXTER HLTHCARE CORP
- 2001BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075759 · RISING
- 2000BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075559 · HOSPIRA
- 1999BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075342 · HOSPIRA
- 1998BUTORPHANOL TARTRATE PRESERVATIVE FREEGeneric (ANDA)
ANDA 075170 · HOSPIRA
- 1998BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 075046 · HIKMA
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.
