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Diethylpropion HCl Controlled-Release

70015427 Diethylpropion HCl USP     CIV Immediate-Release 25 mg Tablets Diethylpropion HCl USP     CIV Controlled-Release 75 mg Tablets

Approved
Approval ID

b26c2f51-7436-4622-a174-3f3978a1fda2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 24, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-876
Application NumberNDA011722
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diethylpropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2009
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
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT

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