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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 075774


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NDA 075774 describes AMMONIUM LACTATE, which is a drug marketed by Padagis Israel, Taro, and Watson Labs Inc, and is included in six NDAs. It is available from six 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. Six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 075774
Mechanism of ActionAcidifying 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 45802-493-83 2 TUBE in 1 CARTON (45802-493-83) / 140 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 12% BASE
Approval Date:May 1, 2002TE:ABRLD:No

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