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Generated: November 19, 2018

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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 three 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-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 010187
Tradename:RITALIN
Applicant:Novartis
Ingredient:methylphenidate hydrochloride
Patents:0
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)

Profile for product number 003

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

Profile for product number 006

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

Profile 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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