FDA Orange Book · active-ingredient family
Soybean oil
Soybean oil is approved in 12 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:INTRALIPID 20% · NDA 020248
12
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INTRALIPID 20%RLD | FRESENIUS | NDA 020248 | AP | Aug 07, 1996 | |
| INTRALIPID 30%RLD | FRESENIUS | NDA 019942 | — | Dec 30, 1993 | |
| NUTRILIPID 10%RLD×2 | B BRAUN | NDA 019531 | — | May 28, 1993 | |
| INTRALIPID 10%RLD | FRESENIUS | NDA 017643 | — | Approved Prior to Jan 1, 1982 | |
| INTRALIPID 20%RLD | FRESENIUS | NDA 018449 | AP | Approved Prior to Jan 1, 1982 | |
| LIPOSYN III 30% | HOSPIRA | NDA 020181 | — | Jan 13, 1998 | |
| LIPOSYN III 20% | HOSPIRA | NDA 018970 | — | Sep 25, 1984 | |
| LIPOSYN III 10% | HOSPIRA | NDA 018969 | — | Sep 24, 1984 | |
| SOYACAL 10% | ALPHA THERA | NDA 018465 | — | Jun 29, 1983 | |
| SOYACAL 20% | ALPHA THERA | NDA 018786 | — | Jun 29, 1983 | |
| TRAVAMULSION 20% | BAXTER HLTHCARE | NDA 018758 | — | Feb 15, 1983 | |
| TRAVAMULSION 10% | BAXTER HLTHCARE | NDA 018660 | — | Feb 26, 1982 |
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.
Soybean oil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
