Details for New Drug Application (NDA): 065439
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NDA 065439 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.
Summary for 065439
| Tradename: | AZTREONAM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | aztreonam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065439
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZTREONAM | aztreonam | INJECTABLE;INJECTION | 065439 | ANDA | Fresenius Kabi USA, LLC | 63323-401 | 63323-401-26 | 10 VIAL in 1 TRAY (63323-401-26) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-21) |
| AZTREONAM | aztreonam | INJECTABLE;INJECTION | 065439 | ANDA | Fresenius Kabi USA, LLC | 63323-401 | 63323-401-24 | 10 VIAL in 1 TRAY (63323-401-24) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Jun 18, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Jun 18, 2010 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Jun 18, 2010 | TE: | AP | RLD: | No | ||||
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