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FDA Approval

Detrol

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

FDA Approval Summary

Company
Effective Date
September 29, 2021
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.

Detrol

Product Details

NDC Product Code
0009-4544
Application Number
NDA020771
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 29, 2021
Code: 5T619TQR3RClass: ACTIBQuantity: 2 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Detrol

Product Details

NDC Product Code
0009-4541
Application Number
NDA020771
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
September 29, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 5T619TQR3RClass: ACTIBQuantity: 1 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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