APPLICATION
ANDA072076
TYPE
ANDA
ORIGINAL APPROVAL
1988-03-24
LATEST ACTION
2023-05-16
ROUTE
PARENTERAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NALOXONE HYDROCHLORIDEPrescription
NALOXONE HYDROCHLORIDE 1MG/ML · INJECTABLE · INJECTION
Approval history
2023-05-16Labeling · Supplement 24 · standardAP
2023-05-16Labeling · Supplement 22 · standardAP
2015-07-31Labeling · Supplement 19 · standardAP
2013-10-30Labeling · Supplement 17 · standardAP
2008-06-04Manufacturing (CMC) · Supplement 14AP
2002-07-18Manufacturing (CMC) · Supplement 12AP
2002-07-18Labeling · Supplement 13AP
1998-01-14Manufacturing (CMC) · Supplement 7AP
1996-06-10Labeling · Supplement 11AP
1995-09-19Manufacturing (CMC) · Supplement 10AP
1995-02-06Labeling · Supplement 8AP
1994-06-17Manufacturing (CMC) · Supplement 9AP
1993-10-29Manufacturing (CMC) · Supplement 6AP
1988-05-20Labeling · Supplement 2AP
1988-04-22Labeling · Supplement 1AP
1988-03-24OriginalAP
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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