Product Details for NDA 021692
ULTRAM ER (TRAMADOL HYDROCHLORIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 001
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ULTRAM ER (TRAMADOL HYDROCHLORIDE)
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 001
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 002
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ULTRAM ER (TRAMADOL HYDROCHLORIDE)
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 002
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 003
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ULTRAM ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021692
Product Number: 003
Approval Date: Sep 8, 2005
Applicant Holder Full Name: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
Marketing Status: Discontinued
Patent and Exclusivity Information