Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085551
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROXYZINE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Discontinued None No No
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/24/1979 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/18/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/19/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/06/1991 SUPPL-30 Labeling

Label is not available on this site.

05/21/1991 SUPPL-29 Labeling

Label is not available on this site.

04/24/1990 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/12/1989 SUPPL-27 Labeling

Label is not available on this site.

05/01/1989 SUPPL-26 Labeling

Label is not available on this site.

12/09/1988 SUPPL-24 Labeling

Label is not available on this site.

10/17/1988 SUPPL-22 Labeling

Label is not available on this site.

10/22/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/27/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/19/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/30/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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