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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
October 30, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tolterodine(2 mg in 1 1)

Products2

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
0093-7163
Application Number
ANDA079141
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 20, 2023
Code: 5T619TQR3RClass: ACTIBQuantity: 2 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403CClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT

Tolterodine Tartrate

Product Details

NDC Product Code
0093-7164
Application Number
ANDA079141
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 20, 2023
Code: 5T619TQR3RClass: ACTIBQuantity: 4 mg in 1 1
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403CClass: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PWClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
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