Last Updated: June 19, 2026

Details for New Drug Application (NDA): 062982

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NDA 062982 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 062982

Tradename:	AMPICILLIN TRIHYDRATE
Applicant:	Ph Health
Ingredient:	ampicillin/ampicillin trihydrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Feb 10, 1989	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 250MG BASE/5ML
Approval Date:	Feb 10, 1989	TE:		RLD:	No

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