Tolterodine tartrate

Registrants1

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

Ajanta Pharma Limited

DUNS Number

918594859

Manufacturing Establishments1

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

Ajanta Pharma Ltd., Dahej

Labeler

Ajanta Pharma USA Inc.

Registrant

Ajanta Pharma Limited

DUNS Number

862199968

Products2

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

Product Details

NDC Product Code

27241-192

Application Number

ANDA213397

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 24, 2021

Ingredients

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

OLEIC ACIDInactive

Code: 2UMI9U37CPClass: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7UClass: IACT

TolterodineActive

Code: 5T619TQR3RClass: ACTIBQuantity: 4 mg in 1 1

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT