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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204115

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NDA 204115 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mallinckrodt Inc, Mayne Pharma, Teva Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Tedor Pharma Inc, Able, Actavis Elizabeth, Cnty Line Pharms, Kremers Urban Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Ascent Pharms Inc, Mallinckrodt, Sun Pharm Inds Inc, Ucb Inc, and Vintage Pharms, and is included in thirty-eight NDAs. It is available from twenty-nine suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 204115

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

Pharmacology for NDA: 204115

Suppliers and Packaging for NDA: 204115

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204115 ANDA Novel Laboratories, Inc. 40032-570 40032-570-01 100 TABLET, CHEWABLE in 1 BOTTLE (40032-570-01)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204115 ANDA Novel Laboratories, Inc. 40032-571 40032-571-01 100 TABLET, CHEWABLE in 1 BOTTLE (40032-571-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength2.5MG
Approval Date:Feb 25, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength5MG
Approval Date:Feb 25, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Feb 25, 2015TE:ABRLD:No


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