← FDA DRUG APPROVALS

FDA NDA · NDA021171

DEMEROL

meperidine hydrochloride

Sponsor: HOSPIRA

APPLICATION
NDA021171
TYPE
NDA
ORIGINAL APPROVAL
1942-11-10
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEMEROL · ReferencePrescription
MEPERIDINE HYDROCHLORIDE 75MG/ML · INJECTABLE · INJECTION
DEMEROL · ReferencePrescription
MEPERIDINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
DEMEROL · ReferencePrescription
MEPERIDINE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
DEMEROL · ReferencePrescription
MEPERIDINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 63 · standard — Letter ↗AP
2025-01-07Labeling · Supplement 60 · standard — Label ↗AP
2023-12-15Labeling · Supplement 53 · standard — Label ↗AP
2022-10-21Labeling · Supplement 51 · standard — Label ↗AP
2019-10-07Labeling · Supplement 32 · standard — Label ↗AP
2016-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 25 · standard — Letter ↗AP
2016-06-24Manufacturing (CMC) · Supplement 23AP
2013-04-19Manufacturing (CMC) · Supplement 20AP
2001-08-24Manufacturing (CMC) · Supplement 4AP
2001-01-31Manufacturing (CMC) · Supplement 3AP
1999-12-09Labeling · Supplement 2 · standardAP
1998-11-17Manufacturing (CMC) · Supplement 1AP
1942-11-10UNKNOWN · Original · unknownAP
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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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