Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
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
43063-510Application Number
ANDA091042Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 6, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT