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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202731

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NDA 202731 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Tris Pharma Inc, Teva Pharms, Impax Labs Inc, Teva Pharms Usa, Abhai Inc, Sun Pharm Inds, Novel Labs Inc, Par Pharm Inc, Mylan Pharms Inc, and Intellipharmaceutics, and is included in twelve NDAs. It is available from fifteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for NDA: 202731

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 202731

Suppliers and Packaging for NDA: 202731

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 202731 ANDA Teva Pharmaceuticals USA, Inc. 0093-5554 0093-5554-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5554-01)
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 202731 ANDA Teva Pharmaceuticals USA, Inc. 0093-5562 0093-5562-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5562-01)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Nov 19, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:May 19, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Fish and Richardson
Colorcon
Covington
Federal Trade Commission
Merck
AstraZeneca
Dow
Daiichi Sankyo
Farmers Insurance

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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