Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019463
Company: BAUSCH AND LOMB INC
Company: BAUSCH AND LOMB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT3 | Yes | Yes |
| TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT3 | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/06/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019463s031lbl.pdf | |
| 09/30/2011 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf | |
| 06/05/2006 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf | |
| 12/22/2003 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf | |
| 12/07/2001 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf |