Product Details for ANDA 079108
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 001
Approval Date: Aug 5, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 001
Approval Date: Aug 5, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 002
Approval Date: Aug 5, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 002
Approval Date: Aug 5, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
15MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 003
Approval Date: May 19, 2014
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 003
Approval Date: May 19, 2014
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 004
Approval Date: Dec 21, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 004
Approval Date: Dec 21, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 005
Approval Date: Nov 21, 2013
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079108
Product Number: 005
Approval Date: Nov 21, 2013
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information