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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 065114

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NDA 065114 describes PIPERACILLIN, which is a drug marketed by Istituto Bio Ita Spa, Apotex, Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Milla Pharms, Onesource Specialty, Sagent Pharms Inc, Sandoz, Shandong, and B Braun Medical, and is included in twenty-five NDAs. Additional details are available on the PIPERACILLIN profile page.

The generic ingredient in PIPERACILLIN 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 065114

Tradename:	PIPERACILLIN
Applicant:	Istituto Bio Ita Spa
Ingredient:	piperacillin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 065114

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Nov 14, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 3GM BASE/VIAL
Approval Date:	Nov 14, 2003	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4GM BASE/VIAL
Approval Date:	Nov 14, 2003	TE:		RLD:	No

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