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FDA Approval

TROSPIUM CHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
August 25, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trospium(20 mg in 1 1)

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
62135-742
Application Number
ANDA204945
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 25, 2023
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TrospiumActive
Code: 1E6682427EClass: ACTIBQuantity: 20 mg in 1 1
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