Details for New Drug Application (NDA): 208075
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NDA 208075 describes CEFTAROLINE FOSAMIL, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. Additional details are available on the CEFTAROLINE FOSAMIL profile page.
The generic ingredient in CEFTAROLINE FOSAMIL is ceftaroline fosamil. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
The generic ingredient in CEFTAROLINE FOSAMIL is ceftaroline fosamil. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
Summary for 208075
| Tradename: | CEFTAROLINE FOSAMIL |
| Applicant: | Apotex |
| Ingredient: | ceftaroline fosamil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208075
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTAROLINE FOSAMIL | ceftaroline fosamil | POWDER;INTRAVENOUS | 208075 | ANDA | Apotex Corp. | 60505-6124 | 60505-6124-1 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6124-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6124-0) |
| CEFTAROLINE FOSAMIL | ceftaroline fosamil | POWDER;INTRAVENOUS | 208075 | ANDA | Apotex Corp. | 60505-6125 | 60505-6125-1 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6125-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6125-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 400MG/VIAL | ||||
| Approval Date: | Sep 21, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 600MG/VIAL | ||||
| Approval Date: | Sep 21, 2021 | TE: | AP | RLD: | No | ||||
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