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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204266

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NDA 204266 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in fifteen NDAs. It is available from fourteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for 204266

Tradename:	DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant:	Mylan Pharms Inc
Ingredient:	dexmethylphenidate hydrochloride
Patents:	0
Therapeutic Class:	Central Nervous System Agents

Pharmacology for NDA: 204266

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 204266

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Suppliers and Packaging for NDA: 204266

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204266	ANDA	Mylan Pharmaceuticals Inc.	0378-4080	N	0378-4080-01
DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204266	ANDA	Mylan Pharmaceuticals Inc.	0378-4081	N	0378-4081-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Aug 25, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Aug 25, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Aug 25, 2015	TE:	AB	RLD:	No

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