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FDA ANDA · ANDA077950

ABACAVIR

abacavir sulfate

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA077950
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-14
LATEST ACTION
2024-03-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ABACAVIR SULFATEPrescription
ABACAVIR SULFATE EQ 20MG BASE/ML · SOLUTION · ORAL

Approval history

2024-03-28Labeling · Supplement 11 · standardAP
2019-08-16Labeling · Supplement 9 · standardAP
2018-03-14OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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