APPLICATION
ANDA080454
TYPE
ANDA
ORIGINAL APPROVAL
1973-07-31
LATEST ACTION
1992-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
1992-03-04Labeling · Supplement 17AP
1990-02-22Manufacturing (CMC) · Supplement 11AP
1990-01-22Bioequivalence · Supplement 15AP
1990-01-22Labeling · Supplement 13AP
1990-01-22Labeling · Supplement 12AP
1987-11-24Manufacturing (CMC) · Supplement 10AP
1984-01-23Manufacturing (CMC) · Supplement 6AP
1984-01-23Manufacturing (CMC) · Supplement 5AP
1983-10-03Manufacturing (CMC) · Supplement 4AP
1983-10-03Manufacturing (CMC) · Supplement 3AP
1973-07-31OriginalAP
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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