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Details for New Drug Application (NDA): 206840

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NDA 206840 describes METHYLPHENIDATE HYDROCHLORIDE, which is a drug marketed by Mallinckrodt, Tris Pharma Inc, Novel Labs Inc, Able, Impax Labs Inc, Teva Pharms, Mallinckrodt Inc, Watson Labs, Sun Pharm Inds Inc, Ascent Pharms Inc, Actavis Labs Fl Inc, Actavis Elizabeth, Mylan Pharms Inc, Ucb Inc, Barr Labs Inc, Cnty Line Pharms, Nostrum Labs Inc, Tedor Pharma Inc, Mayne Pharma, Abhai Llc, Vintage Pharms, and Kremers Urban Pharms, and is included in thirty-five NDAs. It is available from thirty suppliers. Additional details are available on the METHYLPHENIDATE HYDROCHLORIDE profile page.

The generic ingredient in METHYLPHENIDATE HYDROCHLORIDE is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 206840

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 206840

Suppliers and Packaging for NDA: 206840

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL 206840 ANDA Alvogen Inc. 47781-538 47781-538-01 100 TABLET in 1 BOTTLE (47781-538-01)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
TABLET;ORAL 206840 ANDA Alvogen Inc. 47781-539 47781-539-01 100 TABLET in 1 BOTTLE (47781-539-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 15, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 15, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 15, 2016TE: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.

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