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Generated: October 22, 2018

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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 Adare Pharms Inc, Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in seventeen NDAs. It is available from eleven suppliers. Additional details are available on the DEXMETHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 078992
Pharmacology for NDA: 078992
Medical Subject Heading (MeSH) Categories for 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)

Profile for product number 003

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

Profile for product number 004

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

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