Details for New Drug Application (NDA): 075629

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. Forty-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

Pharmacology for NDA: 075629

Physiological Effect

Central Nervous System Stimulation

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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	May 9, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	May 9, 2000	TE:	AB	RLD:	No

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