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FDA ANDA · ANDA065425
DEMECLOCYCLINE HYDROCHLORIDE
demeclocycline
Sponsor: AMNEAL PHARM
APPLICATION
ANDA065425
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2013-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEMECLOCYCLINE HYDROCHLORIDEPrescription
DEMECLOCYCLINE HYDROCHLORIDE 150MG · TABLET · ORAL
DEMECLOCYCLINE HYDROCHLORIDEPrescription
DEMECLOCYCLINE HYDROCHLORIDE 300MG · TABLET · ORAL
Approval history
2013-02-05Labeling · Supplement 2AP
2008-02-27OriginalAP
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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