Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022108

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APLENZIN (BUPROPION HYDROBROMIDE)
174MG
Marketing Status: Prescription

Active Ingredient: BUPROPION HYDROBROMIDE
Proprietary Name: APLENZIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 174MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022108
Product Number: 001
Approval Date: Apr 23, 2008
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

APLENZIN (BUPROPION HYDROBROMIDE)
348MG
Marketing Status: Prescription

Active Ingredient: BUPROPION HYDROBROMIDE
Proprietary Name: APLENZIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 348MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022108
Product Number: 002
Approval Date: Apr 23, 2008
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

APLENZIN (BUPROPION HYDROBROMIDE)
522MG
Marketing Status: Prescription

Active Ingredient: BUPROPION HYDROBROMIDE
Proprietary Name: APLENZIN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 522MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022108
Product Number: 003
Approval Date: Apr 23, 2008
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information