Last Updated: June 22, 2026

Details for New Drug Application (NDA): 217815

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NDA 217815 describes AMMONIUM LACTATE, which is a drug marketed by Padagis Israel, Sun Pharma Canada, Watson Labs Inc, and Zydus Lifesciences, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the AMMONIUM LACTATE profile page.

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

Summary for 217815

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

Profile for product number 001

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

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