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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207960


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NDA 207960 describes QUILLICHEW ER, which is a drug marketed by Nextwave Pharms and is included in one NDA. It is available from one supplier. There are ten 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-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 207960
Tradename:QUILLICHEW ER
Applicant:Nextwave Pharms
Ingredient:methylphenidate hydrochloride
Patents:10
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 24478-074 24478-074-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01)
QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NDA NextWave Pharmaceuticals, Inc 24478-075 24478-075-01 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-075-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE, CHEWABLE;ORALStrength20MG
Approval Date:Dec 4, 2015TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 14, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED
Patent:⤷  Try a TrialPatent Expiration:Aug 14, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 14, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING A SUBJECT HAVING ADHD, SAID METHOD COMPRISING ORALLY ADMINISTERING TO SAID SUBJECT A RACEMIC METHYLPHENIDATE CHEWABLE TABLET AS CLAIMED

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