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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212026

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PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
60MG
Marketing Status: Prescription
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: AB
Application Number: A212026
Product Number: 001
Approval Date: Jan 6, 2020
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
80MG
Marketing Status: Prescription
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: AB
Application Number: A212026
Product Number: 002
Approval Date: Jan 6, 2020
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
120MG
Marketing Status: Prescription
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: AB
Application Number: A212026
Product Number: 003
Approval Date: Jan 6, 2020
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
160MG
Marketing Status: Prescription
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: AB
Application Number: A212026
Product Number: 004
Approval Date: Jan 6, 2020
Applicant Holder Full Name: AMTA LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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