Details for New Drug Application (NDA): 203557
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NDA 203557 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Apotex, Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Milla Pharms, Onesource Specialty, Sagent Pharms Inc, Sandoz, Shandong, and B Braun Medical, and is included in twenty-three NDAs. It is available from fourteen suppliers. Additional details are available on the PIPERACILLIN AND TAZOBACTAM profile page.
The generic ingredient in PIPERACILLIN AND TAZOBACTAM is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
The generic ingredient in PIPERACILLIN AND TAZOBACTAM is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 203557
| Tradename: | PIPERACILLIN AND TAZOBACTAM |
| Applicant: | Sandoz |
| Ingredient: | piperacillin sodium; tazobactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 203557
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 203557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 203557 | ANDA | Hospira, Inc | 0409-2999 | 0409-2999-14 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-2999-14) / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 203557 | ANDA | Sandoz Inc | 0781-3180 | 0781-3180-94 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3180-94) / 250 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL | ||||
| Approval Date: | Oct 29, 2014 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | ||||
| Approval Date: | Jul 8, 2021 | TE: | AP | RLD: | No | ||||
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