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Serving leading biopharmaceutical companies globally:

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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

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12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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