Details for New Drug Application (NDA): 202402
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NDA 202402 describes IBUPROFEN LYSINE, which is a drug marketed by Xgen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the IBUPROFEN LYSINE profile page.
The generic ingredient in IBUPROFEN LYSINE is ibuprofen lysine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.
The generic ingredient in IBUPROFEN LYSINE is ibuprofen lysine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen lysine profile page.
Summary for 202402
| Tradename: | IBUPROFEN LYSINE |
| Applicant: | Xgen Pharms |
| Ingredient: | ibuprofen lysine |
| Patents: | 0 |
Pharmacology for NDA: 202402
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 202402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN LYSINE | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 202402 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-1030 | 39822-1030-2 | 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Mar 30, 2016 | TE: | AP | RLD: | No | ||||
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