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Serving 500+ biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Express Scripts
Baxter
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Covington
Harvard Business School
Dow
AstraZeneca
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079031

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NDA 079031 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, Abhai 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-six NDAs. It is available from twenty-nine 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-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 079031

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

Pharmacology for NDA: 079031

Suppliers and Packaging for NDA: 079031

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 079031 ANDA Teva Pharmaceuticals USA, Inc. 0093-5346 0093-5346-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01)
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 079031 ANDA Teva Pharmaceuticals USA, Inc. 0093-5347 0093-5347-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5347-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 13, 2012TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jul 13, 2012TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jul 13, 2012TE:AB1RLD:No


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Serving 500+ biopharmaceutical companies globally:

Moodys
Chubb
Colorcon
Merck
Cantor Fitzgerald
Argus Health
Accenture
Novartis
UBS
Harvard Business School

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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