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FDA ANDA · ANDA070299

NALOXONE HYDROCHLORIDE

nalxone hydrochloride

Sponsor: HIKMA

APPLICATION
ANDA070299
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
2015-03-12
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NALOXONEPrescription
NALOXONE HYDROCHLORIDE 0.4MG/ML · INJECTABLE · INJECTION

Approval history

2015-03-12Labeling · Supplement 17 · standardAP
2000-09-14Manufacturing (CMC) · Supplement 16AP
1999-01-25Manufacturing (CMC) · Supplement 15AP
1999-01-25Manufacturing (CMC) · Supplement 14AP
1997-09-26Manufacturing (CMC) · Supplement 13AP
1996-08-26Manufacturing (CMC) · Supplement 12AP
1993-11-18Manufacturing (CMC) · Supplement 11AP
1993-07-27Manufacturing (CMC) · Supplement 10AP
1993-03-26Labeling · Supplement 9AP
1990-09-25Labeling · Supplement 7AP
1990-02-22Labeling · Supplement 6AP
1989-07-20Labeling · Supplement 5AP
1987-01-29Manufacturing (CMC) · Supplement 1AP
1987-01-29Manufacturing (CMC) · Supplement 2AP
1986-12-19Manufacturing (CMC) · Supplement 4AP
1986-11-03Manufacturing (CMC) · Supplement 3AP
1985-10-22OriginalAP
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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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