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FDA ANDA · ANDA086880

HYDROXYZINE HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA086880
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-17
LATEST ACTION
2016-11-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

HYDROXYZINE HYDROCHLORIDEDiscontinued
HYDROXYZINE HYDROCHLORIDE 10MG/5ML · SYRUP · ORAL

Approval history

2016-11-08Labeling · Supplement 41 · standardAP
2016-03-30Labeling · Supplement 40 · standardAP
2014-06-03Labeling · Supplement 38 · standardAP
2003-04-24Labeling · Supplement 33AP
2000-03-15Manufacturing (CMC) · Supplement 29AP
2000-03-15Manufacturing (CMC) · Supplement 31AP
2000-03-15Manufacturing (CMC) · Supplement 32AP
2000-03-15Manufacturing (CMC) · Supplement 30AP
1998-07-17Manufacturing (CMC) · Supplement 28AP
1995-06-12Manufacturing (CMC) · Supplement 26AP
1992-08-17Manufacturing (CMC) · Supplement 23AP
1991-06-11Manufacturing (CMC) · Supplement 25AP
1990-09-28Manufacturing (CMC) · Supplement 24AP
1990-05-09Labeling · Supplement 22AP
1989-05-31Manufacturing (CMC) · Supplement 19AP
1989-05-31Manufacturing (CMC) · Supplement 21AP
1989-05-31Manufacturing (CMC) · Supplement 20AP
1987-02-24Manufacturing (CMC) · Supplement 17AP
1987-02-24Manufacturing (CMC) · Supplement 18AP
1986-05-09Manufacturing (CMC) · Supplement 16AP
1985-10-02Manufacturing (CMC) · Supplement 15AP
1983-02-10Manufacturing (CMC) · Supplement 13AP
1982-03-30Manufacturing (CMC) · Supplement 8AP
1980-07-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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