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Details for New Drug Application (NDA): 078992

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NDA 078992 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Tris Pharma Inc, Teva Pharms, Impax Labs Inc, Teva Pharms Usa, Abhai Inc, Sun Pharm Inds, Novel Labs Inc, Mylan Pharms Inc, and Intellipharmaceutics, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Twenty suppliers are listed for this compound. There are seven tentative approvals for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for NDA: 078992

Pharmacology for NDA: 078992

Suppliers and Packaging for NDA: 078992

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 078992 ANDA Par Pharmaceuticals, Inc. 49884-428 49884-428-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-01)
DEXMETHYLPHENIDATE HYDROCHLORIDE
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 078992 ANDA Par Pharmaceuticals, Inc. 49884-428 49884-428-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49884-428-10)

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Nov 18, 2013TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Nov 18, 2013TE:ABRLD:No


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