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Details for New Drug Application (NDA): 088191

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NDA 088191 describes LINDANE, which is a drug marketed by Olta Pharms and Wockhardt and is included in four NDAs. It is available from two suppliers. Additional details are available on the LINDANE profile page.

The generic ingredient in LINDANE is lindane. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lindane profile page.

Summary for NDA: 088191

Tradename:
LINDANE
Applicant:
Wockhardt
Ingredient:
lindane
Patents:0
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 088191

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINDANE
lindane
SHAMPOO;TOPICAL 088191 ANDA Morton Grove Pharmaceuticals, Inc. 60432-834 60432-834-60 60 mL in 1 BOTTLE, GLASS (60432-834-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength1%
Approval Date:Sep 18, 1984TE:ATRLD:Yes


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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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