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FDA ANDA · ANDA203963

SILDENAFIL

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA203963
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-18
LATEST ACTION
2025-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SILDENAFIL CITRATEPrescription
SILDENAFIL CITRATE EQ 20MG BASE · TABLET · ORAL

Approval history

2025-03-18Labeling · Supplement 12 · standardAP
2020-02-21Labeling · Supplement 3 · standardAP
2020-02-21Labeling · Supplement 4 · standardAP
2020-02-21Labeling · Supplement 2 · standardAP
2015-11-18UNKNOWN · OriginalAP
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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