Orange Book product · Generic (ANDA)
BUTORPHANOL TARTRATE PRESERVATIVE FREE
BUTORPHANOL TARTRATE
At a glance
Jan 23, 1997
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 1997
29 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BUTORPHANOL TARTRATE
Strength
2MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 074626
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 2009BUTORPHANOL TARTRATEGeneric (ANDA)
ANDA 078247 · 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
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.
