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Serving 500+ biopharmaceutical companies globally:

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Generated: August 19, 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 Mallinckrodt, Tris Pharma Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Actavis Elizabeth, Mylan Pharms Inc, Ucb Inc, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty-six NDAs. It is available from twenty-seven 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-four suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 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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Serving 500+ biopharmaceutical companies globally:

Accenture
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US Army
Argus Health
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Daiichi Sankyo
Fuji
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Baxter

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