Product Details for NDA 207960
QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
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)
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
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)
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
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
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