Orange Book product · Generic (ANDA)
NALBUPHINE HYDROCHLORIDE
NALBUPHINE HYDROCHLORIDE
At a glance
Feb 03, 1989
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 03, 1989
37 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
NALBUPHINE HYDROCHLORIDE
Strength
100MG/10ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
TE code
AP
Application
ANDA 070915
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of NALBUPHINE HYDROCHLORIDE
- 1993NALBUPHINE HYDROCHLORIDEBrand (NDA)
NDA 020200 · ABBVIE
- —NUBAINBrand (NDA)
NDA 018024 · PH HEALTH
- 2024NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216050 · SOMERSET THERAPS LLC
- 2024NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216049 · SOMERSET THERAPS LLC
- 2019NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206506 · RISING
- 2019NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207595 · RISING
- 1998NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074471 · DR REDDYS
- 1989NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072070 · IGI LABS INC
- 1989NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072071 · IGI LABS INC
- 1989NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072072 · IGI LABS INC
- 1989NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072073 · IGI LABS INC
- 1989NALBUPHINE HYDROCHLORIDEGeneric (ANDA)
ANDA 072074 · IGI LABS INC
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.
