APPLICATION
ANDA078192
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-31
LATEST ACTION
2015-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
RANITIDINE HYDROCHLORIDEOver-the-counter
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
Approval history
2015-11-25Labeling · Supplement 14 · standardAP
2012-01-18Manufacturing (CMC) · Supplement 10AP
2007-08-31OriginalAP
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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