Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206306
Company: SOMERSET THERAPS LLC
Company: SOMERSET THERAPS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.1% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 12/07/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206306Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/09/2024 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |