Product Details for ANDA 212244
LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
20MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
80MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 001
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 001
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 002
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 002
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 003
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 003
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
80MG
Marketing Status: Prescription
Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 004
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
LURASIDONE HYDROCHLORIDE (LURASIDONE HYDROCHLORIDE)
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 004
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
120MG
Marketing Status: Prescription
Active Ingredient: LURASIDONE HYDROCHLORIDE
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 005
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LURASIDONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212244
Product Number: 005
Approval Date: Dec 13, 2022
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information