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FDA Approval

Phendimetrazine Tartrate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
March 1, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Phendimetrazine(35 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Life Line Home Care Services, Inc.

Life Line Home Care Services, Inc.

844985374

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phendimetrazine Tartrate

Product Details

NDC Product Code
75921-045
Application Number
ANDA091042
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 1, 2012
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: 6985IP0T80Class: ACTIMQuantity: 35 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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