Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
InvaGen Pharmaceuticals Inc.
165104469
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceuticals Inc.
Exelan Pharmaceuticals Inc.
InvaGen Pharmaceuticals Inc.
080334903
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trospium Chloride
Product Details
NDC Product Code
76282-336Application Number
ANDA091688Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 3, 2018SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TrospiumActive
Code: 1E6682427EClass: ACTIBQuantity: 20 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT