Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050628
Company: HARROW EYE
Company: HARROW EYE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOBRASONE | FLUOROMETHOLONE ACETATE; TOBRAMYCIN | 0.1%;0.3% | SUSPENSION/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 |
---|---|---|---|---|---|---|---|
07/21/1989 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
12/11/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/09/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/07/2001 | SUPPL-1 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/07/2001 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50628S1lbl.pdf |