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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Army
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Fuji
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Julphar
Cerilliant
Colorcon
Novartis
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Generated: August 17, 2017

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, 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: 091189

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Fuji
Mallinckrodt
Cipla
Deloitte
Teva
Johnson and Johnson
Daiichi Sankyo
Citi
Dow
McKinsey

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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