Details for New Drug Application (NDA): 206517
✉ Email this page to a colleague
NDA 206517 describes AZTREONAM, which is a drug marketed by Fresenius Kabi Usa, Hikma, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the AZTREONAM profile page.
The generic ingredient in AZTREONAM is aztreonam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
The generic ingredient in AZTREONAM is aztreonam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
Suppliers and Packaging for NDA: 206517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZTREONAM | aztreonam | INJECTABLE;INJECTION | 206517 | ANDA | Hospira, Inc. | 0409-0829 | 0409-0829-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0829-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0829-11) |
| AZTREONAM | aztreonam | INJECTABLE;INJECTION | 206517 | ANDA | Hospira, Inc. | 0409-0830 | 0409-0830-01 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0830-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0830-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Nov 8, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Nov 8, 2021 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
