Product Details for ANDA 202304
BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
100MG
Marketing Status: Prescription
150MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
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: A202304
Product Number: 001
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
BUPROPION HYDROCHLORIDE (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: A202304
Product Number: 001
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A202304
Product Number: 002
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
BUPROPION HYDROCHLORIDE (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: A202304
Product Number: 002
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A202304
Product Number: 003
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A202304
Product Number: 003
Approval Date: May 26, 2015
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information