APPLICATION
ANDA074918
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-08
LATEST ACTION
2015-09-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NALTREXONE HYDROCHLORIDEPrescription
NALTREXONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2015-09-02Labeling · Supplement 17 · standardAP
2015-09-02Labeling · Supplement 18 · standardAP
2002-11-20Labeling · Supplement 12AP
2002-04-19Manufacturing (CMC) · Supplement 9AP
2001-01-29Labeling · Supplement 8AP
2000-09-14Labeling · Supplement 7AP
1999-12-21Manufacturing (CMC) · Supplement 6AP
1999-11-22Manufacturing (CMC) · Supplement 5AP
1999-11-22Manufacturing (CMC) · Supplement 4AP
1999-05-20Manufacturing (CMC) · Supplement 3AP
1999-03-22Manufacturing (CMC) · Supplement 2AP
1998-12-01Manufacturing (CMC) · Supplement 1AP
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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