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Fish and Richardson
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Federal Trade Commission
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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204772

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NDA 204772 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, Osmotica, Ucb Inc, Barr Labs Inc, Abhai Inc, Cnty Line Pharms, Breckenridge Pharm, Tedor Pharma Inc, Mayne Pharma, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty-eight NDAs. It is available from thirty 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-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 204772

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

Pharmacology for NDA: 204772

Suppliers and Packaging for NDA: 204772

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204772 ANDA County Line Pharmaceuticals, LLC 43199-041 43199-041-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43199-041-01)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 204772 ANDA County Line Pharmaceuticals, LLC 43199-042 43199-042-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43199-042-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Feb 29, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
Dow
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Cantor Fitzgerald
US Army
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QuintilesIMS
Baxter
Harvard Business School
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