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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
Drug Ocean LLC
DUNS: 080381835
Effective Date
October 12, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tolterodine(1 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Unique Pharmaceutical Laboratories

917165052

Manufacturing Establishments1

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

Unique Pharmaceutical Laboratories

Drug Ocean LLC

Unique Pharmaceutical Laboratories

650434645

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
70985-022
Application Number
ANDA204721
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 12, 2023
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TolterodineActive
Code: 5T619TQR3RClass: ACTIBQuantity: 1 mg in 1 1

Tolterodine Tartrate

Product Details

NDC Product Code
70985-023
Application Number
ANDA204721
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 12, 2023
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TolterodineActive
Code: 5T619TQR3RClass: ACTIBQuantity: 2 mg in 1 1
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