Details for New Drug Application (NDA): 050580
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NDA 050580 describes AZACTAM, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the AZACTAM profile page.
The generic ingredient in AZACTAM 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 AZACTAM 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 050580
| Tradename: | AZACTAM |
| Applicant: | Bristol Myers Squibb |
| Ingredient: | aztreonam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZACTAM | aztreonam | INJECTABLE;INJECTION | 050580 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-2560 | 0003-2560-16 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2560-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| AZACTAM | aztreonam | INJECTABLE;INJECTION | 050580 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-2570 | 0003-2570-16 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0003-2570-16) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 31, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
| Approval Date: | Dec 31, 1986 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/VIAL | ||||
| Approval Date: | Dec 31, 1986 | TE: | AP | RLD: | Yes | ||||
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