Details for New Drug Application (NDA): 018449
✉ Email this page to a colleague
NDA 018449 describes INTRALIPID 20%, which is a drug marketed by Fresenius and is included in two NDAs. It is available from three suppliers. Additional details are available on the INTRALIPID 20% profile page.
The generic ingredient in INTRALIPID 20% is soybean oil. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the soybean oil profile page.
The generic ingredient in INTRALIPID 20% is soybean oil. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the soybean oil profile page.
Summary for 018449
| Tradename: | INTRALIPID 20% |
| Applicant: | Fresenius |
| Ingredient: | soybean oil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INTRALIPID 20% | soybean oil | INJECTABLE;INJECTION | 018449 | NDA | Baxter Healthcare Corporation | 0338-0519 | 0338-0519-14 | 1000 mL in 1 BAG (0338-0519-14) |
| INTRALIPID 20% | soybean oil | INJECTABLE;INJECTION | 018449 | NDA | Baxter Healthcare Corporation | 0338-0519 | 0338-0519-04 | 1000 mL in 1 BAG (0338-0519-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Complete Access Available with Subscription
