Details for New Drug Application (NDA): 065458
✉ Email this page to a colleague
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 065458
Tradename: | PIPERACILLIN AND TAZOBACTAM |
Applicant: | Steriscience Speclts |
Ingredient: | piperacillin sodium; tazobactam sodium |
Patents: | 0 |
Pharmacology for NDA: 065458
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 065458
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 065458 | ANDA | Armas Pharmaceuticals Inc. | 72485-403 | 72485-403-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (72485-403-10) / 15 mL in 1 VIAL, SINGLE-DOSE (72485-403-01) |
PIPERACILLIN AND TAZOBACTAM | piperacillin sodium; tazobactam sodium | INJECTABLE;INJECTION | 065458 | ANDA | Armas Pharmaceuticals Inc. | 72485-404 | 72485-404-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (72485-404-10) / 20 mL in 1 VIAL, SINGLE-DOSE (72485-404-01) |
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 15, 2014 | 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 15, 2014 | 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 15, 2014 | TE: | AP | RLD: | No |
Complete Access Available with Subscription