Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AMTA LABS LIMITED
664424833
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Yichang Humanwell Oral Solid Dosage Plant
Slate Run Pharmaceuticals, LLC
AMTA LABS LIMITED
421371958
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
70436-174Application Number
ANDA214760Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 6, 2023GELATINInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77TClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TrospiumActive
Code: 1E6682427EClass: ACTIBQuantity: 60 mg in 1 1