Orange Book product · Brand (NDA)
DIPRIVAN
PROPOFOL
At a glance
Jun 11, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPOFOL
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AB
Application
NDA 019627
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2025PROPOFOLGeneric (ANDA)
ANDA 217945 · EMERGE BIOSCIENCE
- 2024PROPOFOLGeneric (ANDA)
ANDA 217525 · AMNEAL
- 2024PROPOFOLGeneric (ANDA)
ANDA 217013 · ASPIRO
- 2021PROPOFOLGeneric (ANDA)
ANDA 206408 · AVET LIFESCIENCES
- 2020PROPOFOLGeneric (ANDA)
ANDA 205576 · INNOPHARMA
- 2018PROPOFOLGeneric (ANDA)
ANDA 205067 · DR REDDYS
- 2015PROPOFOLGeneric (ANDA)
ANDA 205307 · WATSON LABS INC
- 2006PROPOFOLGeneric (ANDA)
ANDA 077908 · HOSPIRA
- 2005PROPOFOLGeneric (ANDA)
ANDA 074848 · HIKMA
- 2000PROPOFOLGeneric (ANDA)
ANDA 075392 · TEVA PARENTERAL
- 1999PROPOFOLGeneric (ANDA)
ANDA 075102 · SAGENT PHARMS 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.
