Product Details for NDA 022370
CONZIP (TRAMADOL HYDROCHLORIDE)
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
150MG
Marketing Status: Discontinued
100MG
Marketing Status: Prescription
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022370
Product Number: 001
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CONZIP (TRAMADOL HYDROCHLORIDE)
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022370
Product Number: 001
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 002
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CONZIP (TRAMADOL HYDROCHLORIDE)
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 002
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 003
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
CONZIP (TRAMADOL HYDROCHLORIDE)
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 003
Approval Date: May 7, 2010
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
150MG
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 004
Approval Date: Aug 1, 2011
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CONZIP
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022370
Product Number: 004
Approval Date: Aug 1, 2011
Applicant Holder Full Name: CIPHER PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information