Product Details for ANDA 078703
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
60MG
Marketing Status: Prescription
80MG
Marketing Status: Prescription
120MG
Marketing Status: Prescription
160MG
Marketing Status: Prescription
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: A078703
Product Number: 001
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A078703
Product Number: 001
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078703
Product Number: 002
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A078703
Product Number: 002
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078703
Product Number: 003
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A078703
Product Number: 003
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A078703
Product Number: 004
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
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: AB
Application Number: A078703
Product Number: 004
Approval Date: Jul 15, 2011
Applicant Holder Full Name: ADARE PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information