Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Epic Pharma, LLC
827915443
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Epic Pharma, LLC
Epic Pharma, LLC
Epic Pharma, LLC
827915443
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
42806-058Application Number
ANDA076835Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 27, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816NClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FlavoxateActive
Code: 9C05J6089WClass: ACTIBQuantity: 100 mg in 1 1