Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020281

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ULTRAM (TRAMADOL HYDROCHLORIDE)
50MG Marketing Status: Prescription

Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: ULTRAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020281
Product Number: 002
Approval Date: Mar 3, 1995
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ULTRAM (TRAMADOL HYDROCHLORIDE)
100MG Marketing Status: Discontinued

Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: ULTRAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020281
Product Number: 001
Approval Date: Mar 3, 1995
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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