APLENZIN
These highlights do not include all the information needed to use APLENZIN safely and effectively. See full prescribing information for APLENZIN. APLENZIN (bupropion hydrobromide) tablet, film coated, extended release for oral use Initial U.S. Approval: 1985
Approved
Approval ID
2315d6e5-144d-4163-9711-f855c759cf8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BUPROPION HYDROBROMIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-922
Application NumberNDA022108
Product Classification
M
Marketing Category
C73594
G
Generic Name
BUPROPION HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 10, 2011
FDA Product Classification
INGREDIENTS (8)
ETHYLCELLULOSE (100 MPA.S)Inactive
Code: 47MLB0F1MV
Classification: IACT
BUPROPION HYDROBROMIDEActive
Quantity: 348 mg in 1 1
Code: E70G3G5863
Classification: ACTIB
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT