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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
Actavis Pharma, Inc.
DUNS: 119723554
Effective Date
August 1, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trospium(60 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
0591-3636
Application Number
ANDA091289
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 1, 2014
TrospiumActive
Code: 1E6682427EClass: ACTIBQuantity: 60 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77TClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
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