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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Boehringer Ingelheim

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202580

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NDA 202580 describes DEXMETHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Abhai Inc, Lannett, Novel Labs Inc, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in fourteen NDAs. It is available from fourteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for 202580

Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 202580

Medical Subject Heading (MeSH) Categories for 202580

Suppliers and Packaging for NDA: 202580

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202580 ANDA Mylan Pharmaceuticals Inc. 0378-4084 0378-4084-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4084-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Aug 28, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Express Scripts

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