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FDA ANDA · ANDA040163

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: SPECGX LLC

APPLICATION
ANDA040163
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-12
LATEST ACTION
2023-12-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2023-12-15Labeling · Supplement 5 · standardAP
2019-10-11Labeling · Supplement 4 · standardAP
2019-09-23Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 1 · standardAP
2016-12-16Labeling · Supplement 2 · standardAP
1997-05-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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