APPLICATION
ANDA087408
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-27
LATEST ACTION
2016-11-08
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
HYDROXYZINE HYDROCHLORIDE · ReferencePrescription
HYDROXYZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
HYDROXYZINE HYDROCHLORIDE · ReferencePrescription
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
Approval history
2016-11-08Labeling · Supplement 26 · standardAP
2016-03-30Labeling · Supplement 25 · standardAP
2014-06-03Labeling · Supplement 22 · standardAP
2003-01-02Labeling · Supplement 15AP
2002-07-17Manufacturing (CMC) · Supplement 14AP
1997-09-25Manufacturing (CMC) · Supplement 13AP
1996-02-28Manufacturing (CMC) · Supplement 12AP
1992-12-24Labeling · Supplement 11AP
1992-04-02Labeling · Supplement 10AP
1991-09-13Manufacturing (CMC) · Supplement 7AP
1991-09-04Labeling · Supplement 9AP
1991-05-22Manufacturing (CMC) · Supplement 8AP
1981-08-27OriginalAP
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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