Details for New Drug Application (NDA): 207648
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NDA 207648 describes SMOFLIPID 20%, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the SMOFLIPID 20% profile page.
The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.
The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.
Summary for 207648
| Tradename: | SMOFLIPID 20% |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | fish oil; medium chain triglycerides; olive oil; soybean oil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207648
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648 | NDA | Fresenius Kabi USA, LLC | 63323-820 | 63323-820-00 | 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) |
| SMOFLIPID 20% | fish oil; medium chain triglycerides; olive oil; soybean oil | EMULSION;INTRAVENOUS | 207648 | NDA | Fresenius Kabi USA, LLC | 63323-820 | 63323-820-10 | 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | ||||
| Approval Date: | Jul 13, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | ||||
| Approval Date: | Jul 13, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;INTRAVENOUS | Strength | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | ||||
| Approval Date: | Jul 13, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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