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FDA NDA · NDA005010

DEMEROL

Sponsor: QUAGEN

APPLICATION
NDA005010
TYPE
NDA
ORIGINAL APPROVAL
1942-11-10
LATEST ACTION
2026-06-18
ROUTE
ORAL, INJECTION
DOSAGE FORM
TABLET, INJECTABLE, SYRUP
MARKETING STATUS
Discontinued

Products

DEMEROL · ReferenceDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DEMEROLDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
DEMEROLDiscontinued
MEPERIDINE HYDROCHLORIDE 75MG/ML · INJECTABLE · INJECTION
DEMEROLDiscontinued
MEPERIDINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
DEMEROLDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
DEMEROLDiscontinued
MEPERIDINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
DEMEROL · ReferenceDiscontinued
MEPERIDINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 63 — Letter ↗AP
2025-12-22Labeling · Supplement 62 · standard — Letter ↗AP
2024-10-31REMS · Supplement 61 — Letter ↗AP
2023-12-15Labeling · Supplement 60 · standard — Label ↗AP
2021-03-04Labeling · Supplement 59 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 58 · standard — Letter ↗AP
2018-09-18REMS · Supplement 56 — Letter ↗AP
2018-09-18Labeling · Supplement 57 · standard — Letter ↗AP
2017-08-16Labeling · Supplement 55 · standard — Label ↗AP
2016-12-16Labeling · Supplement 54 · standard — Letter ↗AP
2011-10-31Labeling · Supplement 51 · standard — Letter ↗AP
2011-04-11Labeling · Supplement 50 · standard — Letter ↗AP
2009-03-05Labeling · Supplement 49 · standard — Letter ↗AP
2003-05-15Labeling · Supplement 48 · standard — Letter ↗AP
2003-02-26Labeling · Supplement 47 · standard — Letter ↗AP
2000-10-17Manufacturing (CMC) · Supplement 46 · standardAP
1997-07-24Labeling · Supplement 31AP
1995-10-10Manufacturing (CMC) · Supplement 45 · standardAP
1995-03-16Manufacturing (CMC) · Supplement 44 · standardAP
1995-03-16Manufacturing (CMC) · Supplement 42 · standardAP
1995-03-16Manufacturing (CMC) · Supplement 43 · standardAP
1992-09-29Manufacturing (CMC) · Supplement 40 · standardAP
1992-09-29Manufacturing (CMC) · Supplement 39 · standardAP
1992-09-10Manufacturing (CMC) · Supplement 41 · standardAP
1992-07-30Manufacturing (CMC) · Supplement 38 · standardAP
1991-02-12Manufacturing (CMC) · Supplement 37 · standardAP
1990-09-12Manufacturing (CMC) · Supplement 36 · standardAP
1990-01-25Manufacturing (CMC) · Supplement 35 · standardAP
1989-05-25Manufacturing (CMC) · Supplement 33 · standardAP
1989-05-24Manufacturing (CMC) · Supplement 34 · standardAP
1989-04-03Manufacturing (CMC) · Supplement 32 · standardAP
1988-01-06Labeling · Supplement 30AP
1986-07-18Labeling · Supplement 29AP
1986-05-12Manufacturing (CMC) · Supplement 28 · standardAP
1985-06-04Manufacturing (CMC) · Supplement 27 · standardAP
1985-05-20Manufacturing (CMC) · Supplement 25 · standardAP
1985-05-20Manufacturing (CMC) · Supplement 26 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 24 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 23 · standardAP
1983-03-28Manufacturing (CMC) · Supplement 21 · standardAP
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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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