Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210634
Company: TORRENT
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 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
02/26/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

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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