Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213757
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | 0.665MG/SPRAY | SPRAY, METERED;NASAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/13/2023 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |