Diethylpropion HCl Immediate-Release
Diethylpropion HCl USP CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP CIV Controlled-Release 75 mg Tablets
Approved
Approval ID
04bd05c4-0d36-4580-94ec-2119d8d58644
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 2
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 Code68387-696
Application NumberANDA011722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (6)
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
Diethylpropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-695
Application NumberANDA011722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIETHYLPROPION HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 19V2PL39NG
Classification: ACTIB
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT