Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077847
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | EQ 2% BASE;EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077847s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2025 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/03/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/04/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |