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Serving leading biopharmaceutical companies globally:

Fuji
Deloitte
Colorcon
Harvard Business School
Healthtrust
US Army
Merck
McKinsey
Mallinckrodt
Daiichi Sankyo

Generated: November 23, 2017

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Details for New Drug Application (NDA): 201466

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NDA 201466 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Mallinckrodt, Tris Pharma Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Actavis Elizabeth, Mylan Pharms Inc, Osmotica, Ucb Inc, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Breckenridge Pharm, Tedor Pharma Inc, Mayne Pharma, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty-eight NDAs. It is available from thirty suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 201466

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201466

Suppliers and Packaging for NDA: 201466

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
SOLUTION;ORAL 201466 ANDA Breckenridge Pharmaceutical, Inc. 51991-611 51991-611-50 500 mL in 1 BOTTLE (51991-611-50)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
SOLUTION;ORAL 201466 ANDA Breckenridge Pharmaceutical, Inc. 51991-612 51991-612-50 500 mL in 1 BOTTLE (51991-612-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Nov 12, 2013TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Nov 12, 2013TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Harvard Business School
Dow
Merck
Baxter
Accenture
Fish and Richardson
Moodys
Mallinckrodt

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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