Product Details for ANDA 203583
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 001
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 001
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 002
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 002
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 003
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 003
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 004
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 004
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 005
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 005
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 006
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A203583
Product Number: 006
Approval Date: Sep 29, 2015
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information