Last Updated: November 13, 2026

Details for New Drug Application (NDA): 217758

NDA 217758 describes AMMONIUM LACTATE, which is a drug marketed by Padagis Israel, Sun Pharma Canada, Watson Labs Inc, and Zydus Lifesciences, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the AMMONIUM LACTATE profile page.

The generic ingredient in AMMONIUM LACTATE is ammonium lactate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.

Summary for 217758

Tradename:	AMMONIUM LACTATE
Applicant:	Zydus Lifesciences
Ingredient:	ammonium lactate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	EQ 12% BASE
Approval Date:	May 15, 2026	TE:	AB	RLD:	No

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