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FDA Approval

Tolterodine Tartrate

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

FDA Approval Summary

Company
Effective Date
August 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tolterodine(4 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolterodine Tartrate

Product Details

NDC Product Code
50090-3475
Application Number
ANDA079141
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 20, 2023
Code: 5T619TQR3RClass: ACTIBQuantity: 4 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403CClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
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