Details for New Drug Application (NDA): 206030
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NDA 206030 describes CARNEXIV, which is a drug marketed by Lundbeck Pharms Llc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the CARNEXIV profile page.
The generic ingredient in CARNEXIV is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
The generic ingredient in CARNEXIV is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 206030
| Tradename: | CARNEXIV |
| Applicant: | Lundbeck Pharms Llc |
| Ingredient: | carbamazepine |
| Patents: | 7 |
Suppliers and Packaging for NDA: 206030
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARNEXIV | carbamazepine | SOLUTION;INTRAVENOUS | 206030 | NDA | Lundbeck Pharmaceuticals LLC | 67386-621 | 67386-621-52 | 1 VIAL, GLASS in 1 CARTON (67386-621-52) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
| Approval Date: | Oct 7, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 11,529,357 | Patent Expiration: | Jan 31, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,635,773 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,410,077 | Patent Expiration: | Mar 13, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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