TRIZIVIR

TRIZIVIR

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

FDA Approval Summary

Company

ViiV Healthcare Company

DUNS: 027295585

Effective Date

February 17, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lamivudine(150 mg in 1 1)

Abacavir(300 mg in 1 1)

Zidovudine(300 mg in 1 1)

Products1

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

Product Details

NDC Product Code

49702-217

Application Number

NDA021205

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

April 27, 2018

Ingredients

LamivudineActive

Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1

AbacavirActive

Code: J220T4J9Q2Class: ACTIMQuantity: 300 mg in 1 1

ZidovudineActive

Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

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TRIZIVIR

FDA Approval Summary

Products1

TRIZIVIR

Product Details