Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trospium Chloride ER
Product Details
NDC Product Code
63629-8458Application Number
ANDA201291Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 22, 2021MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TrospiumActive
Code: 1E6682427EClass: ACTIBQuantity: 60 mg in 1 1
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT