Product Details for ANDA 204349
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
60MG
Marketing Status: Discontinued
80MG
Marketing Status: Discontinued
120MG
Marketing Status: Discontinued
160MG
Marketing Status: Discontinued
60MG
Marketing Status: Discontinued
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 001
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 001
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
80MG
Marketing Status: Discontinued
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 002
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 002
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
120MG
Marketing Status: Discontinued
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 003
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 120MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 003
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
160MG
Marketing Status: Discontinued
Active Ingredient: PROPRANOLOL HYDROCHLORIDE
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 160MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 004
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 160MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A204349
Product Number: 004
Approval Date: Jan 12, 2024
Applicant Holder Full Name: LUPIN LTD
Marketing Status: Discontinued
Patent and Exclusivity Information