Product Details for ANDA 073144
CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
5MG
Marketing Status: Discontinued
7.5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 002
Approval Date: Feb 3, 2006
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 002
Approval Date: Feb 3, 2006
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
Patent and Exclusivity Information
7.5MG
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 003
Approval Date: Mar 25, 2013
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 003
Approval Date: Mar 25, 2013
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 001
Approval Date: May 30, 1991
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
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:
Application Number: A073144
Product Number: 001
Approval Date: May 30, 1991
Applicant Holder Full Name: RISING PHARMA HOLDING INC
Marketing Status: Discontinued
Patent and Exclusivity Information