FDA.reportPublic FDA data

Application 087294

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESYRUP;ORAL10MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-4822Hydroxyzine HydrochlorideHydroxyzine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
17856-0150Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0150Hydroxyzine HydrochlorideHydroxyzine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0150Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAtlantic Biologicals CorpsANDACurrent
50090-0276Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
60432-150Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
63187-494Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
63187-494Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
63187-494Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
63629-1855Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
68151-0150Hydroxyzine HydrochlorideHydroxyzine HydrochlorideCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73375SUPPL 2023-02-02
73374SUPPL 2023-02-02
39593SUPPL2014-06-24
31431SUPPL2014-06-11