Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040675
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 5MG/5ML;6.25MG/5ML | SYRUP;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
12/23/2014 | ORIG-1 | Approval |
Label is not available on this site. |