Orange Book product · Brand (NDA)
STADOL
BUTORPHANOL TARTRATE
At a glance
Dec 12, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
BUTORPHANOL TARTRATE
Strength
1MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SPRAY, METERED
Route
NASAL
TE code
Not listed
Application
NDA 019890
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —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
- 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.
