Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207960

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QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)
20MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: QUILLICHEW ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE, CHEWABLE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207960
Product Number: 001
Approval Date: Dec 4, 2015
Applicant Holder Full Name: NEXTWAVE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: QUILLICHEW ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE, CHEWABLE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207960
Product Number: 002
Approval Date: Dec 4, 2015
Applicant Holder Full Name: NEXTWAVE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: QUILLICHEW ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE, CHEWABLE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207960
Product Number: 003
Approval Date: Dec 4, 2015
Applicant Holder Full Name: NEXTWAVE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information