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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022370

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CONZIP (TRAMADOL HYDROCHLORIDE)
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)
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)
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)
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
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