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FDA Approval

Demeclocycline Hydrochloride

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

FDA Approval Summary

Company

Amneal Pharmaceuticals LLC

DUNS: 123797875

Effective Date

May 18, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Demeclocycline(150 mg in 1 1)

Products2

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

Demeclocycline Hydrochloride

Product Details

NDC Product Code

65162-554

Application Number

ANDA065425

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 18, 2018

Ingredients

DemeclocyclineActive

Code: 29O079NTYTClass: ACTIBQuantity: 150 mg in 1 1

ALGINIC ACIDInactive

Code: 8C3Z4148WZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Demeclocycline Hydrochloride

Product Details

NDC Product Code

65162-555

Application Number

ANDA065425

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 18, 2018

Ingredients

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DemeclocyclineActive

Code: 29O079NTYTClass: ACTIBQuantity: 300 mg in 1 1

ALGINIC ACIDInactive

Code: 8C3Z4148WZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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