Diethylpropion Hydrochloride
Diethylpropion Hydrochloride Extended Release Tablets, 75 mgCIVRx only
Approved
Approval ID
89306917-a65b-40d4-9c51-d59ac0ad2017
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diethylpropion Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0049
Application NumberANDA091680
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diethylpropion Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2019
FDA Product Classification
INGREDIENTS (7)
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT