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Phendimetrazine Tartrate

Phendimetrazine Tartrate 35mg Tablet

Approved
Approval ID

f31c768e-4156-4ebe-8dce-763bf940ab1b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2011

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.

Phendimetrazine Tartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-597
Application NumberANDA085588
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phendimetrazine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification

INGREDIENTS (8)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
PHENDIMETRAZINE TARTRATEActive
Quantity: 35 mg in 1 1
Code: 6985IP0T80
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Phendimetrazine Tartrate - FDA Drug Approval Details