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FDA Approval

Thioridazine Hydrochloride

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

FDA Approval Summary

Company

Mylan Institutional Inc.

DUNS: 039615992

Effective Date

December 16, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Thioridazine(100 mg in 1 1)

Products4

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

Thioridazine Hydrochloride

Product Details

NDC Product Code

51079-580

Application Number

ANDA088004

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

ThioridazineActive

Code: 4WCI67NK8MClass: ACTIBQuantity: 100 mg in 1 1

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Thioridazine Hydrochloride

Product Details

NDC Product Code

51079-565

Application Number

ANDA088004

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ThioridazineActive

Code: 4WCI67NK8MClass: ACTIBQuantity: 10 mg in 1 1

Thioridazine Hydrochloride

Product Details

NDC Product Code

51079-567

Application Number

ANDA088004

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ThioridazineActive

Code: 4WCI67NK8MClass: ACTIBQuantity: 50 mg in 1 1

Thioridazine Hydrochloride

Product Details

NDC Product Code

51079-566

Application Number

ANDA088004

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 16, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ThioridazineActive

Code: 4WCI67NK8MClass: ACTIBQuantity: 25 mg in 1 1

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