Product Details for ANDA 217268
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
EQ 1MG BASE
Marketing Status: Prescription
EQ 2MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: PRAZOSIN HYDROCHLORIDE
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 001
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 001
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: PRAZOSIN HYDROCHLORIDE
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 002
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 002
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: PRAZOSIN HYDROCHLORIDE
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 003
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PRAZOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217268
Product Number: 003
Approval Date: Mar 6, 2023
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information