Product Details for ANDA 211779
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 001
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 001
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 002
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 002
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 003
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211779
Product Number: 003
Approval Date: Oct 4, 2019
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information