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FDA ANDA · ANDA081002
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
Sponsor: WEST-WARD PHARMS INT
APPLICATION
ANDA081002
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEPrescription
MEPERIDINE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2025-12-22Labeling · Supplement 13 · standardAP
2024-01-03Labeling · Supplement 11 · standardAP
2024-01-03Labeling · Supplement 12 · standardAP
2019-10-11Labeling · Supplement 10 · standardAP
2019-09-23Labeling · Supplement 9 · standardAP
2017-05-02Labeling · Supplement 8 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 6AP
1995-09-05Labeling · Supplement 5AP
1995-09-05Labeling · Supplement 4AP
1995-08-29Manufacturing (CMC) · Supplement 3AP
1994-09-29Manufacturing (CMC) · Supplement 1AP
1994-06-10Labeling · Supplement 2AP
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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