FDA.reportPublic FDA data

Application 078870

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-029Cetirizine Hydrochloride Oral SolutionCetirizine Hydrochloride Oral SolutionTorrent Pharma, Inc.ANDACurrent
13668-029Cetirizine Hydrochloride Oral SolutionCetirizine Hydrochloride Oral SolutionTorrent Pharma, Inc.ANDACurrent
13668-029Cetirizine Hydrochloride Oral SolutionCetirizine Hydrochloride Oral SolutionTorrent Pharma, Inc.ANDACurrent
13668-596Cetirizine HydrochlorideCetirizine HydrochlorideTorrent Pharmaceuticals LimitedANDACurrent
13668-596Cetirizine HydrochlorideCetirizine HydrochlorideTorrent Pharma Inc.ANDACurrent
23155-292Cetirizine hydrochlorideCetirizine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
50090-2659Cetirizine hydrochlorideCetirizine hydrochlorideA-S Medication SolutionsANDACurrent
50090-2659Cetirizine hydrochlorideCetirizine hydrochlorideA-S Medication SolutionsANDACurrent
50090-3885Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3885Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
68788-9985Cetirizine hydrochlorideCetirizine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent