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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091695

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NDA 091695 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-eight 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 091695
Tradename:METHYLPHENIDATE HYDROCHLORIDE
Applicant:Kremers Urban Pharms
Ingredient:methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091695
Suppliers and Packaging for NDA: 091695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 091695 ANDA Kremers Urban Pharmaceuticals Inc. 62175-310 62175-310-37 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-310-37)
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 091695 ANDA Kremers Urban Pharmaceuticals Inc. 62175-311 62175-311-37 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62175-311-37)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength18MG
Approval Date:Jul 9, 2013TE:BXRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength27MG
Approval Date:Jul 9, 2013TE:BXRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength36MG
Approval Date:Sep 23, 2013TE:BXRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Dow
Chubb
Healthtrust
Farmers Insurance
Argus Health
Fuji
Moodys

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