← FDA DRUG APPROVALS

FDA NDA · NDA018890

METRONIDAZOLE IN PLASTIC CONTAINER

Sponsor: HOSPIRA

APPLICATION
NDA018890
TYPE
NDA
ORIGINAL APPROVAL
1983-11-18
LATEST ACTION
2025-03-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METRONIDAZOLE IN PLASTIC CONTAINER · ReferencePrescription
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION

Approval history

2025-03-14Labeling · Supplement 58 · standard — Label ↗AP
2024-07-08Labeling · Supplement 57 · standard — Letter ↗AP
2023-10-06Labeling · Supplement 55 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 54 · standard — Label ↗AP
2021-03-05Labeling · Supplement 53 · standard — Letter ↗AP
2018-04-03Labeling · Supplement 52 · standard — Label ↗AP
2016-01-22Manufacturing (CMC) · Supplement 51AP
2015-07-13Labeling · Supplement 50 · standard — Letter ↗AP
2014-08-01Manufacturing (CMC) · Supplement 49AP
2008-10-14Labeling · Supplement 44AP
2004-01-26Labeling · Supplement 32AP
2002-11-01Manufacturing (CMC) · Supplement 31AP
1999-07-06Manufacturing (CMC) · Supplement 30AP
1998-12-01Manufacturing (CMC) · Supplement 29AP
1997-06-02Manufacturing (CMC) · Supplement 28AP
1997-04-08Manufacturing (CMC) · Supplement 27AP
1996-07-03Manufacturing (CMC) · Supplement 25AP
1996-03-12Manufacturing (CMC) · Supplement 26AP
1993-12-03Labeling · Supplement 23AP
1993-06-23Labeling · Supplement 22AP
1992-02-24Manufacturing (CMC) · Supplement 21AP
1991-04-24Manufacturing (CMC) · Supplement 20AP
1990-09-19Manufacturing (CMC) · Supplement 19AP
1990-09-19Manufacturing (CMC) · Supplement 17AP
1989-11-20Labeling · Supplement 18AP
1989-08-17Labeling · Supplement 16AP
1987-07-28Manufacturing (CMC) · Supplement 13AP
1987-07-28Manufacturing (CMC) · Supplement 12AP
1987-03-11Manufacturing (CMC) · Supplement 11AP
1987-03-11Manufacturing (CMC) · Supplement 9AP
1986-06-03Manufacturing (CMC) · Supplement 5AP
1986-01-17Manufacturing (CMC) · Supplement 7AP
1986-01-17Manufacturing (CMC) · Supplement 6AP
1985-05-13Manufacturing (CMC) · Supplement 4AP
1985-04-02Manufacturing (CMC) · Supplement 3AP
1984-07-24Manufacturing (CMC) · Supplement 2AP
1983-11-18OriginalAP
VIEW ON DRUGS@FDA ↗

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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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