APPLICATION
ANDA074251
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2024-06-10
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CIMETIDINE HYDROCHLORIDEPrescription
CIMETIDINE HYDROCHLORIDE EQ 300MG BASE/5ML · SOLUTION · ORAL
Approval history
2024-06-10Labeling · Supplement 5 · standardAP
2002-01-17Manufacturing (CMC) · Supplement 4AP
2000-06-22Manufacturing (CMC) · Supplement 3AP
1996-07-10Labeling · Supplement 2AP
1995-11-09Manufacturing (CMC) · Supplement 1AP
1994-12-22OriginalAP
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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