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FDA Approval

Zidovudine

CompanyAurobindo Pharma Limited (DUNS: 650082092)

Effective Date

January 25, 2024

Labeling Type

Human Prescription Drug Label

Active Ingredients

Zidovudine(300 mg in 1 1)

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

Products (1)

Zidovudine

NDC Product Code

65862-024

Application Number

ANDA077267

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 25, 2024

Ingredients

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

ZidovudineActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

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