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FDA ANDA · ANDA091052

DOXYCYCLINE HYCLATE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA091052
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-08
LATEST ACTION
2016-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 150MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2016-12-02Labeling · Supplement 9 · standardAP
2016-12-02Labeling · Supplement 7 · standardAP
2016-12-02Labeling · Supplement 6 · standardAP
2014-11-04Labeling · Supplement 3 · standardAP
2012-03-25Manufacturing (CMC) · Supplement 1AP
2012-02-08OriginalLetterAP
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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