Product Details for ANDA 212719
LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
100MG
Marketing Status: Discontinued
200MG
Marketing Status: Discontinued
300MG
Marketing Status: Discontinued
100MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 001
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 001
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 002
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 002
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG
Marketing Status: Discontinued
Active Ingredient: LABETALOL HYDROCHLORIDE
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 003
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LABETALOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A212719
Product Number: 003
Approval Date: Aug 8, 2022
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status: Discontinued
Patent and Exclusivity Information