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FDA ANDA · ANDA207774

DOXYCYCLINE HYCLATE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
ANDA207774
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-31
LATEST ACTION
2023-07-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2023-07-25Labeling · Supplement 4 · standardAP
2019-09-05Labeling · Supplement 1 · standardAP
2018-05-31UNKNOWN · Original · standardAP
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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