Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211347

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

Active Ingredient: BUPROPION HYDROCHLORIDE
Proprietary Name: BUPROPION HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211347
Product Number: 001
Approval Date: Oct 16, 2018
Applicant Holder Full Name: YICHANG HUMANWELL PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
150MG
Marketing Status: Prescription

Active Ingredient: BUPROPION HYDROCHLORIDE
Proprietary Name: BUPROPION HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211347
Product Number: 002
Approval Date: Oct 16, 2018
Applicant Holder Full Name: YICHANG HUMANWELL PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: BUPROPION HYDROCHLORIDE
Proprietary Name: BUPROPION HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211347
Product Number: 003
Approval Date: Oct 16, 2018
Applicant Holder Full Name: YICHANG HUMANWELL PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information