FDA Orange Book · active-ingredient family
Propofol
Propofol is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIPRIVAN · NDA 019627
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIPRIVANRLD×2 | FRESENIUS KABI USA | NDA 019627 | AB | Jun 11, 1996 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPOFOL | EMERGE BIOSCIENCE | ANDA 217945 | AB | Dec 02, 2025 | |
| PROPOFOL | AMNEAL | ANDA 217525 | AB | Aug 15, 2024 | |
| PROPOFOL | ASPIRO | ANDA 217013 | AB | Jun 20, 2024 | |
| PROPOFOL | AVET LIFESCIENCES | ANDA 206408 | AB | Oct 12, 2021 | |
| PROPOFOL | INNOPHARMA | ANDA 205576 | AB | Sep 16, 2020 | |
| PROPOFOL | DR REDDYS | ANDA 205067 | AB | Nov 15, 2018 | |
| PROPOFOL | WATSON LABS INC | ANDA 205307 | — | Dec 22, 2015 | |
| PROPOFOL | HOSPIRA | ANDA 077908 | AB | Mar 17, 2006 | |
| PROPOFOL | HIKMA | ANDA 074848 | AB | Apr 19, 2005 | |
| PROPOFOL | TEVA PARENTERAL | ANDA 075392 | — | Sep 19, 2000 | |
| PROPOFOL | SAGENT PHARMS INC | ANDA 075102 | AB | Jan 04, 1999 |
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.
Propofol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
