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Generated: November 12, 2018

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Details for New Drug Application (NDA): 075629

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NDA 075629 describes METHYLIN ER, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from one supplier. Additional details are available on the METHYLIN ER profile page.

The generic ingredient in METHYLIN ER is methylphenidate hydrochloride. There are thirty-two 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 075629
Tradename:METHYLIN ER
Applicant:Specgx Llc
Ingredient:methylphenidate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075629
Suppliers and Packaging for NDA: 075629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629 ANDA SpecGx LLC 0406-1445 0406-1445-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1445-01)
METHYLIN ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 075629 ANDA SpecGx LLC 0406-1473 0406-1473-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-1473-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 9, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:May 9, 2000TE:ABRLD:No

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