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Serving leading biopharmaceutical companies globally:

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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203846

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NDA 203846 describes METHAMPHETAMINE HYDROCHLORIDE, which is a drug marketed by Able, Mayne Pharma Inc, Rexar, Teva, and West-ward Pharms Int, and is included in five NDAs. It is available from three suppliers. Additional details are available on the METHAMPHETAMINE HYDROCHLORIDE profile page.

The generic ingredient in METHAMPHETAMINE HYDROCHLORIDE is methamphetamine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.
Summary for 203846
Applicant:West-ward Pharms Int
Ingredient:methamphetamine hydrochloride
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203846
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 203846 ANDA West-Ward Pharmaceuticals Corp. 0054-0389 0054-0389-25 100 TABLET in 1 BOTTLE (0054-0389-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 17, 2015TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
US Army
US Department of Justice

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