Details for New Drug Application (NDA): 204959
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NDA 204959 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, Milla Pharms, Onesource Specialty, Sagent Pharms Inc, Sandoz, Shandong, Wockhardt Bio Ag, and B Braun Medical, and is included in twenty-three NDAs. It is available from fifteen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 204959
| Tradename: | PIPERACILLIN AND TAZOBACTAM |
| Applicant: | Shandong |
| Ingredient: | piperacillin sodium; tazobactam sodium |
| Patents: | 0 |
Pharmacology for NDA: 204959
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 204959
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 204959 | ANDA | Shandong Anxin Pharmaceutical Co., Ltd. | 35369-0501 | 35369-0501-2 | 10 VIAL, SINGLE-DOSE in 1 CARTON (35369-0501-2) / 20 mL in 1 VIAL, SINGLE-DOSE (35369-0501-1) |
| PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 204959 | ANDA | Shandong Anxin Pharmaceutical Co., Ltd. | 35369-0502 | 35369-0502-2 | 10 VIAL, SINGLE-DOSE in 1 CARTON (35369-0502-2) / 10 mL in 1 VIAL, SINGLE-DOSE (35369-0502-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | ||||
| Approval Date: | Aug 10, 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: | Aug 10, 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: | Aug 10, 2018 | TE: | AP | RLD: | No | ||||
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