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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020508

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NDA 020508 describes LAC-HYDRIN, which is a drug marketed by Ranbaxy and is included in two NDAs. It is available from one supplier. Additional details are available on the LAC-HYDRIN profile page.

The generic ingredient in LAC-HYDRIN is ammonium lactate. There are thirty-seven 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 020508

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020508

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAC-HYDRIN ammonium lactate CREAM;TOPICAL 020508 NDA Ranbaxy Laboratories Inc. 10631-099 10631-099-38 385 g in 1 BOTTLE, PLASTIC (10631-099-38)
LAC-HYDRIN ammonium lactate CREAM;TOPICAL 020508 NDA Ranbaxy Laboratories Inc. 10631-099 10631-099-28 140 g in 1 TUBE (10631-099-28)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrengthEQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 29, 1996TE:RLD:No


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