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Details for New Drug Application (NDA): 078458

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NDA 078458 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: 078458

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

Pharmacology for NDA: 078458

Suppliers and Packaging for NDA: 078458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 078458 ANDA Actavis Pharma, Inc. 45963-200 45963-200-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-11)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 078458 ANDA Actavis Pharma, Inc. 45963-200 45963-200-25 250 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-25)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Dec 1, 2011TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 1, 2011TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Dec 1, 2011TE:AB1RLD:No


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