Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087294
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/12/1982 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
11/08/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

03/30/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

06/03/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087294Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/087294Orig1s026ltr.pdf
04/04/2005 SUPPL-23 Labeling

Label is not available on this site.

06/13/2003 SUPPL-21 Labeling

Label is not available on this site.

08/22/2002 SUPPL-20 Labeling

Label is not available on this site.

12/27/1993 SUPPL-19 Labeling

Label is not available on this site.

02/11/1991 SUPPL-18 Labeling

Label is not available on this site.

02/11/1991 SUPPL-17 Labeling

Label is not available on this site.

02/11/1991 SUPPL-16 Labeling

Label is not available on this site.

06/19/1990 SUPPL-15 Labeling

Label is not available on this site.

09/08/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/20/1989 SUPPL-13 Labeling

Label is not available on this site.

02/07/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/09/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/22/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/13/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/03/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087294Orig1s026lbl.pdf

HYDROXYZINE HYDROCHLORIDE

SYRUP;ORAL; 10MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription No AA 040010 HI TECH PHARMA
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription No AA 201674 LANNETT CO INC
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription No AA 210634 TORRENT
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription No AA 040391 VINTAGE PHARMS
HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE 10MG/5ML SYRUP;ORAL Prescription No AA 087294 WOCKHARDT BIO AG

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