Product Details for ANDA 077563
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
7.5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 001
Approval Date: Apr 19, 2006
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 001
Approval Date: Apr 19, 2006
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
7.5MG
Marketing Status: Prescription
Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 003
Approval Date: Aug 25, 2017
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 003
Approval Date: Aug 25, 2017
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 002
Approval Date: Apr 19, 2006
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077563
Product Number: 002
Approval Date: Apr 19, 2006
Applicant Holder Full Name: JUBILANT CADISTA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information