Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLAVOXATE HYDROCHLORIDE
Product Details
NDC Product Code
68151-3826Application Number
ANDA076831Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 24, 2014FlavoxateActive
Code: 9C05J6089WClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ETHYL ACRYLATEInactive
Code: 71E6178C9TClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688Class: IACT
NONOXYNOL-100Inactive
Code: A906T4D368Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT