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Serving leading biopharmaceutical companies globally:

Queensland Health
Dow
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UBS
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Generated: October 22, 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 Tris Pharma Inc, Teva Pharms, Impax Labs Inc, Teva Pharms Usa, Abhai Inc, Sun Pharm Inds, Novel Labs Inc, Par Pharm Inc, Mylan Pharms Inc, Lannett, and Intellipharmaceutics, and is included in fourteen NDAs. It is available from fifteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for NDA: 202580

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 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
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