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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 078908

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NDA 078908 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Adare Pharms Inc, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Alkem Labs Ltd, Bionpharma Inc, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in nineteen NDAs. It is available from twelve 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 078908
Pharmacology for NDA: 078908
Medical Subject Heading (MeSH) Categories for 078908
Suppliers and Packaging for NDA: 078908
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908 ANDA Teva Pharmaceuticals USA, Inc. 0093-5550 0093-5550-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5550-01)
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908 ANDA Teva Pharmaceuticals USA, Inc. 0093-5551 0093-5551-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5551-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 19, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 19, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Nov 19, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Johnson and Johnson
AstraZeneca
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Mallinckrodt

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