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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202608

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NDA 202608 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: 202608

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

Pharmacology for NDA: 202608

Suppliers and Packaging for NDA: 202608

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202608 ANDA Mallinckrodt, Inc. 0406-0127 0406-0127-01 100 TABLET in 1 BOTTLE (0406-0127-01)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202608 ANDA Mallinckrodt, Inc. 0406-0136 0406-0136-01 100 TABLET in 1 BOTTLE (0406-0136-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength27MG
Approval Date:Dec 28, 2012TE:BXRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength36MG
Approval Date:Dec 28, 2012TE:BXRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength54MG
Approval Date:Dec 28, 2012TE:BXRLD:No


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