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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, 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 four 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: 202580

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
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.