Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 200503

Expand all

TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: TRAMADOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB1
Application Number: A200503
Product Number: 001
Approval Date: Aug 29, 2011
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
200MG
Marketing Status: Prescription

Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: TRAMADOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A200503
Product Number: 002
Approval Date: Aug 29, 2011
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
300MG
Marketing Status: Prescription

Active Ingredient: TRAMADOL HYDROCHLORIDE
Proprietary Name: TRAMADOL HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A200503
Product Number: 003
Approval Date: Aug 29, 2011
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information