APPLICATION
ANDA040352
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-13
LATEST ACTION
2023-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG · TABLET · ORAL
MEPERIDINE HYDROCHLORIDEDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2023-12-15Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 5AP
2005-11-03Labeling · Supplement 4AP
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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