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Last Updated: January 23, 2020

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Details for New Drug Application (NDA): 091189

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NDA 091189 describes METHAMPHETAMINE HYDROCHLORIDE, which is a drug marketed by Able, Hikma, Mayne Pharma Inc, Rexar, and Teva, and is included in five NDAs. It is available from two 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. Three suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.
Summary for 091189
Applicant:Mayne Pharma Inc
Ingredient:methamphetamine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHAMPHETAMINE HYDROCHLORIDE methamphetamine hydrochloride TABLET;ORAL 091189 ANDA Mayne Pharma Inc. 68308-115 68308-115-01 100 TABLET in 1 BOTTLE, PLASTIC (68308-115-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 21, 2010TE:AARLD:No

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