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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201404

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NDA 201404 describes AMPICILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Istituto Bio Ita Spa, Lilly, Onesource Specialty, Sagent Pharms Inc, Sandoz, and Watson Labs Inc, and is included in twenty-five NDAs. It is available from eighteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

Summary for 201404

Tradename:	AMPICILLIN SODIUM
Applicant:	Istituto Bio Ita Spa
Ingredient:	ampicillin sodium
Patents:	0

Pharmacology for NDA: 201404

Medical Subject Heading (MeSH) Categories for 201404

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	201404	ANDA	Sagent Pharmaceuticals	25021-197	25021-197-99	1 BOTTLE in 1 CARTON (25021-197-99) / 100 mL in 1 BOTTLE
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	201404	ANDA	Athenex Pharmaceutical Division, LLC.	70860-118	70860-118-99	1 BOTTLE in 1 CARTON (70860-118-99) / 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Dec 20, 2013	TE:	AP	RLD:	No

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