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FDA ANDA · ANDA088185

HYDROXYZINE HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA088185
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-31
LATEST ACTION
2007-05-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

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

Approval history

2007-05-21Manufacturing (CMC) · Supplement 15AP
1991-10-22Labeling · Supplement 13AP
1991-05-29Labeling · Supplement 12AP
1991-03-18Labeling · Supplement 11AP
1990-10-05Manufacturing (CMC) · Supplement 10AP
1990-10-05Manufacturing (CMC) · Supplement 9AP
1990-10-05Manufacturing (CMC) · Supplement 8AP
1988-05-27Manufacturing (CMC) · Supplement 7AP
1987-07-06Manufacturing (CMC) · Supplement 5AP
1987-07-06Manufacturing (CMC) · Supplement 6AP
1983-03-31Original — Other ↗AP
VIEW ON DRUGS@FDA ↗

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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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