Last Updated: November 13, 2026

Details for New Drug Application (NDA): 075774

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NDA 075774 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 075774

Tradename:	AMMONIUM LACTATE
Applicant:	Padagis Israel
Ingredient:	ammonium lactate
Patents:	0

Pharmacology for NDA: 075774

Mechanism of Action	Acidifying Activity

Suppliers and Packaging for NDA: 075774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMMONIUM LACTATE	ammonium lactate	CREAM;TOPICAL	075774	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-493	45802-493-26	385 g in 1 BOTTLE, PUMP (45802-493-26)
AMMONIUM LACTATE	ammonium lactate	CREAM;TOPICAL	075774	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-493	45802-493-38	385 g in 1 BOTTLE (45802-493-38)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	EQ 12% BASE
Approval Date:	May 1, 2002	TE:	AB	RLD:	No

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