PHENDIMETRAZINE TARTRATE
PHENDIMETRAZINE TARTRATE TABLETS, USP 35 mg Rx Only
Approved
Approval ID
42ecacde-6859-47c6-ba44-13fb4f3b5448
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2019
Manufacturers
FDA
Elite Laboratories, Inc
DUNS: 785398728
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phendimetrazine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-440
Application NumberANDA040762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2019
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT