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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Daiichi Sankyo
Cipla
UBS
Cerilliant
US Army
Julphar
AstraZeneca
Argus Health

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 010187

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NDA 010187 describes RITALIN, which is a drug marketed by Novartis and is included in three NDAs. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RITALIN profile page.

The generic ingredient in RITALIN 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 010187

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

Pharmacology for NDA: 010187

Suppliers and Packaging for NDA: 010187

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RITALIN
methylphenidate hydrochloride
TABLET;ORAL 010187 NDA Novartis Pharmaceuticals Corporation 0078-0439 0078-0439-05 100 TABLET in 1 BOTTLE (0078-0439-05)
RITALIN
methylphenidate hydrochloride
TABLET;ORAL 010187 NDA Novartis Pharmaceuticals Corporation 0078-0440 0078-0440-05 100 TABLET in 1 BOTTLE (0078-0440-05)

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 006

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 010

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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Serving leading biopharmaceutical companies globally:

Merck
Cipla
Harvard Business School
McKesson
Cerilliant
Baxter
Johnson and Johnson
Healthtrust
US Army
Fuji

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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