Details for New Drug Application (NDA): 203719
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NDA 203719 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience Speclts, and Wockhardt Bio Ag, and is included in twenty-two 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 203719
| Tradename: | PIPERACILLIN AND TAZOBACTAM |
| Applicant: | Fresenius Kabi |
| Ingredient: | piperacillin sodium; tazobactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 203719
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 203719
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 203719 | ANDA | Fresenius Kabi USA, LLC | 63323-981 | 63323-981-21 | 10 VIAL, SINGLE-USE in 1 CARTON (63323-981-21) / 10 mL in 1 VIAL, SINGLE-USE (63323-981-23) |
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 203719 | ANDA | Fresenius Kabi USA, LLC | 63323-981 | 63323-981-53 | 10 VIAL, SINGLE-USE in 1 CARTON (63323-981-53) / 10 mL in 1 VIAL, SINGLE-USE (63323-981-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | ||||
| Approval Date: | May 18, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | ||||
| Approval Date: | May 18, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | ||||
| Approval Date: | May 18, 2018 | TE: | AP | RLD: | No | ||||
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