Orange Book product · Brand (NDA)
LEVO-DROMORAN
LEVORPHANOL TARTRATE
At a glance
Dec 19, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 1991
35 yr ago
Today
Pharmaceutical detail
Active ingredient
LEVORPHANOL TARTRATE
Strength
2MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 008719
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1991LEVO-DROMORANBrand (NDA)
NDA 008720 · VALEANT PHARM INTL
- 2021LEVORPHANOL TARTRATEGeneric (ANDA)
ANDA 213479 · NOVITIUM PHARMA
- 2021LEVORPHANOL TARTRATEGeneric (ANDA)
ANDA 213906 · SUN PHARM INDS INC
- 2019LEVORPHANOL TARTRATEGeneric (ANDA)
ANDA 212024 · SPECGX LLC
- 2018LEVORPHANOL TARTRATEGeneric (ANDA)
ANDA 211484 · ACERTIS PHARMS
- 2018LEVORPHANOL TARTRATEGeneric (ANDA)
ANDA 074278 · 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.
