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FDA ANDA · ANDA204446

DOXYCYCLINE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA204446
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-28
LATEST ACTION
2016-08-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DOXYCYCLINEDiscontinued
DOXYCYCLINE EQ 100MG BASE · CAPSULE · ORAL
DOXYCYCLINEDiscontinued
DOXYCYCLINE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINEDiscontinued
DOXYCYCLINE EQ 75MG BASE · CAPSULE · ORAL

Approval history

2016-08-17Labeling · Supplement 1 · standardAP
2016-08-17Manufacturing (CMC) · Supplement 2 · unknownAP
2015-05-28UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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