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Details for New Drug Application (NDA): 207960

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NDA 207960 describes QUILLICHEW ER, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the QUILLICHEW ER profile page.

The generic ingredient in QUILLICHEW ER is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-five 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: 207960

Tradename:
QUILLICHEW ER
Applicant:
Pfizer Inc
Ingredient:
methylphenidate hydrochloride
Patents:4
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 207960

Suppliers and Packaging for NDA: 207960

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NDA NextWave Pharmaceuticals, Inc. 24478-120 24478-120-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-120-01)
QUILLICHEW ER
methylphenidate hydrochloride
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NDA NextWave Pharmaceuticals, Inc. 24478-130 24478-130-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-130-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE, CHEWABLE;ORALStrength20MG
Approval Date:Dec 4, 2015TE:RLD:No
Patent:8,202,537Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,287,903Patent Expiration:Feb 15, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:8,999,386Patent Expiration:Aug 14, 2033Product Flag?YSubstance Flag?Delist Request?


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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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