Details for New Drug Application (NDA): 208675

NDA 208675 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 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. Seventeen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for 208675

Tradename:	PIPERACILLIN AND TAZOBACTAM
Applicant:	Sagent Pharms Inc
Ingredient:	piperacillin sodium; tazobactam sodium
Patents:	0

Pharmacology for NDA: 208675

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 208675

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	208675	ANDA	Sagent Pharmaceuticals	25021-181	25021-181-99	1 BOTTLE in 1 CARTON (25021-181-99) / 152 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:	Feb 16, 2021	TE:	AP	RLD:	No

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