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Details for New Drug Application (NDA): 207488

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NDA 207488 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Mallinckrodt, Tris Pharma Inc, Novel Labs Inc, Able, Corepharma, 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, Cnty Line Pharms, Tedor Pharma Inc, Mayne Pharma, Nostrum Labs Inc, Abhai, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty-two 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-five suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 207488

Tradename:
METHYLPHENIDATE HYDROCHLORIDE
Applicant:
Abhai
Ingredient:
methylphenidate hydrochloride
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 207488

Suppliers and Packaging for NDA: 207488

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 207488 ANDA KVK-Tech, Inc. 10702-075 10702-075-01 100 TABLET in 1 BOTTLE (10702-075-01)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 207488 ANDA KVK-Tech, Inc. 10702-075 10702-075-06 60 TABLET in 1 BOTTLE (10702-075-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 9, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 9, 2015TE:ABRLD:No


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