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FDA Approval

ODEFSEY

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

FDA Approval Summary

Company

Gilead Sciences, Inc.

DUNS: 185049848

Effective Date

February 6, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Emtricitabine(200 mg in 1 1)

Rilpivirine(25 mg in 1 1)

Tenofovir(25 mg in 1 1)

Products1

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

ODEFSEY

Product Details

NDC Product Code

61958-2101

Application Number

NDA208351

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

September 17, 2021

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

EmtricitabineActive

Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

RilpivirineActive

Code: 212WAX8KDDClass: ACTIMQuantity: 25 mg in 1 1

TenofovirActive

Code: FWF6Q91TZOClass: ACTIRQuantity: 25 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYSORBATE 20Inactive

Code: 7T1F30V5YHClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Warnings and Precautions, New Onset or Worsening Renal Impairment (5.5)

03/2021

BOXED WARNING SECTION

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

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