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Serving leading biopharmaceutical companies globally:

Baxter
Novartis
QuintilesIMS
Covington
Medtronic
Moodys
Chubb
McKesson
UBS
Julphar

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091189

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NDA 091189 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 091189
Tradename:METHAMPHETAMINE HYDROCHLORIDE
Applicant:Mayne Pharma Inc
Ingredient:methamphetamine hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
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 Mylan Pharmaceuticals Inc. 0378-8115 0378-8115-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-8115-01)
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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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Johnson and Johnson
Deloitte
Covington
Accenture
Healthtrust
Argus Health
McKesson
Colorcon

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