TROSPIUM CHLORIDE
These highlights do not include all the information needed to use TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES. TROSPIUM CHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
c1c8bd8b-7ff8-5940-e053-2995a90ae656
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TROSPIUM CHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-174
Application NumberANDA214760
Product Classification
M
Marketing Category
C73584
G
Generic Name
TROSPIUM CHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
INGREDIENTS (16)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TROSPIUM CHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1E6682427E
Classification: ACTIB