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Generated: July 25, 2017

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Details for New Drug Application (NDA): 203846

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NDA 203846 describes METHAMPHETAMINE HYDROCHLORIDE, which is a drug marketed by Able, Rexar, West-ward Pharms Int, Teva, and Mayne Pharma Inc, 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 NDA: 203846

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
TABLET;ORAL 203846 ANDA West-Ward Pharmaceuticals Corp. 0054-0389 0054-0389-25 100 TABLET in 1 BOTTLE (0054-0389-25)

Summary for product number 001

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

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