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FDA ANDA · ANDA091479

SILDENAFIL

Sponsor: TORRENT PHARMS LTD

APPLICATION
ANDA091479
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-06
LATEST ACTION
2019-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2019-04-02Labeling · Supplement 11 · standardAP
2019-04-02Labeling · Supplement 10 · standardAP
2015-12-17Labeling · Supplement 7 · standardAP
2015-04-03Labeling · Supplement 5 · standardAP
2014-08-15Labeling · Supplement 2 · standardAP
2012-11-06OriginalLetterAP
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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