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FDA ANDA · ANDA081309

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: INTL MEDICATION

APPLICATION
ANDA081309
TYPE
ANDA
ORIGINAL APPROVAL
1993-08-30
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
MEPERIDINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 13 · standardAP
2025-12-22Labeling · Supplement 12 · standardAP
2023-12-15Labeling · Supplement 11 · standardAP
2019-10-11Labeling · Supplement 10 · standardAP
2019-09-27Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 7 · standardAP
1998-01-14Manufacturing (CMC) · Supplement 1AP
1995-09-19Manufacturing (CMC) · Supplement 6AP
1995-07-25Manufacturing (CMC) · Supplement 5AP
1994-06-17Manufacturing (CMC) · Supplement 4AP
1994-04-18Labeling · Supplement 3AP
1994-04-18Manufacturing (CMC) · Supplement 2AP
1993-08-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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