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FDA ANDA · ANDA087329

HYDROXYZINE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA087329
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-11
LATEST ACTION
2016-11-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION
HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION

Approval history

2016-11-08Labeling · Supplement 22 · standardAP
2016-03-30Labeling · Supplement 21 · standardAP
2014-09-25Labeling · Supplement 20 · standard — Letter ↗AP
2014-06-04Labeling · Supplement 19 · standard — Letter ↗AP
2002-12-05Manufacturing (CMC) · Supplement 14AP
1996-07-05Manufacturing (CMC) · Supplement 10AP
1996-06-24Manufacturing (CMC) · Supplement 12AP
1994-09-23Manufacturing (CMC) · Supplement 8AP
1993-06-23Labeling · Supplement 9AP
1990-03-20Labeling · Supplement 7AP
1984-12-13Manufacturing (CMC) · Supplement 6AP
1984-10-02Manufacturing (CMC) · Supplement 5AP
1984-10-02Manufacturing (CMC) · Supplement 4AP
1982-10-13Manufacturing (CMC) · Supplement 1AP
1981-08-11OriginalAP
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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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