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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 061602

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NDA 061602 describes AMPICILLIN TRIHYDRATE, which is a drug marketed by Aurobindo Pharma, Belcher Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Strides Pharma Intl, Vitarine, Ph Health, and Teva, and is included in sixteen NDAs. It is available from three suppliers. Additional details are available on the AMPICILLIN TRIHYDRATE profile page.

The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.

Summary for 061602

Tradename:	AMPICILLIN TRIHYDRATE
Applicant:	Belcher Pharms
Ingredient:	ampicillin/ampicillin trihydrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 250MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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