Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210634
Company: APOZEAL PHARMS
Company: APOZEAL PHARMS
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 | 210634 | APOZEAL PHARMS |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 087294 | CHARTWELL RX |
HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;ORAL | Prescription | No | AA | 201674 | LANNETT CO INC |