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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202198

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NDA 202198 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 seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

Summary for 202198

Tradename:	AMPICILLIN SODIUM
Applicant:	Onesource Specialty
Ingredient:	ampicillin sodium
Patents:	0

Pharmacology for NDA: 202198

Medical Subject Heading (MeSH) Categories for 202198

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 202198

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	202198	ANDA	Armas Pharmaceuticals Inc.	72485-423	72485-423-10	1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (72485-423-10)
AMPICILLIN SODIUM	ampicillin sodium	INJECTABLE;INJECTION	202198	ANDA	Steriscience Specialties Private Limited	82449-515	82449-515-01	1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (82449-515-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Apr 7, 2014	TE:	AP	RLD:	No

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