Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021745

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RYZOLT (TRAMADOL HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: RYZOLT
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021745
Product Number: 001
Approval Date: Dec 30, 2008
Applicant Holder Full Name: PURDUE PHARMA PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
RYZOLT (TRAMADOL HYDROCHLORIDE)
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: RYZOLT
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021745
Product Number: 002
Approval Date: Dec 30, 2008
Applicant Holder Full Name: PURDUE PHARMA PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
RYZOLT (TRAMADOL HYDROCHLORIDE)
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: RYZOLT
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021745
Product Number: 003
Approval Date: Dec 30, 2008
Applicant Holder Full Name: PURDUE PHARMA PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

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