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FDA NDA · NDA011730

MEPERGAN

Sponsor: HIKMA

APPLICATION
NDA011730
TYPE
NDA
ORIGINAL APPROVAL
1961-11-13
LATEST ACTION
2025-12-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MEPERGANDiscontinued
MEPERIDINE HYDROCHLORIDE 25MG/ML, PROMETHAZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 34 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 33 · standard — Label ↗AP
2019-10-07Labeling · Supplement 32 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 31 · standard — Letter ↗AP
1999-08-19Labeling · Supplement 23AP
1995-11-29Manufacturing (CMC) · Supplement 29 · priorityAP
1994-02-28Manufacturing (CMC) · Supplement 28 · priorityAP
1993-10-25Manufacturing (CMC) · Supplement 27 · priorityAP
1989-02-17Manufacturing (CMC) · Supplement 22 · priorityAP
1989-01-13Manufacturing (CMC) · Supplement 24 · priorityAP
1982-10-06Manufacturing (CMC) · Supplement 14 · priorityAP
1982-10-06Manufacturing (CMC) · Supplement 15 · priorityAP
1982-10-06Manufacturing (CMC) · Supplement 13 · priorityAP
1981-10-20Manufacturing (CMC) · Supplement 9 · priorityAP
1978-10-23Labeling · Supplement 8AP
1978-10-05Manufacturing (CMC) · Supplement 7 · priorityAP
1961-11-13Type 4 - New Combination · Original · priorityAP
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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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