Product Details for ANDA 212990
LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 001
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 001
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 002
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 002
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 003
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
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: AB
Application Number: A212990
Product Number: 003
Approval Date: Sep 30, 2020
Applicant Holder Full Name: EPIC PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information