Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Elite Laboratories, Inc.
785398728
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Elite Laboratories, Inc.
Elite Laboratories, Inc
Elite Laboratories, Inc.
785398728
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
64850-440Application Number
ANDA040762Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 7, 2019SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
PhendimetrazineActive
Code: 6985IP0T80Class: ACTIBQuantity: 35 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT