DICLOFENAC SODIUM

Registrants (1)

DIRECTRX

DUNS Number

079254320

Manufacturing Establishments (1)

DIRECTRX

Labeler

DIRECTRX

Registrant

DIRECTRX

DUNS Number

079254320

Products (1)

DICLOFENAC SODIUM E/R

NDC Product Code

61919-608

Application Number

ANDA075492

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 9, 2023

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive

Code: ZYD53NBL45Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 100 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

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Registrants (1)

Manufacturing Establishments (1)

Products (1)

DICLOFENAC SODIUM E/R