Details for New Drug Application (NDA): 017643
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NDA 017643 describes INTRALIPID 10%, which is a drug marketed by Fresenius and is included in one NDA. It is available from one supplier. Additional details are available on the INTRALIPID 10% profile page.
The generic ingredient in INTRALIPID 10% 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 10% 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 017643
| Tradename: | INTRALIPID 10% |
| Applicant: | Fresenius |
| Ingredient: | soybean oil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 017643
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INTRALIPID 10% | soybean oil | INJECTABLE;INJECTION | 017643 | NDA | Baxter Healthcare CORP | 0338-0518 | 0338-0518-12 | 250 mL in 1 BAG (0338-0518-12) |
| INTRALIPID 10% | soybean oil | INJECTABLE;INJECTION | 017643 | NDA | Baxter Healthcare CORP | 0338-0518 | 0338-0518-13 | 500 mL in 1 BAG (0338-0518-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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