Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018086
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 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | Yes | No |
| TIMOPTIC | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/17/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2021 | SUPPL-80 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018086Orig1s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018086Orig1s080ltr.pdf | |
| 08/09/2016 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018086Orig1s076ltr.pdf | |
| 09/30/2011 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018086s075ltr.pdf | |
| 04/26/2006 | SUPPL-72 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf | |
| 04/26/2006 | SUPPL-70 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018086s070,s072ltr.pdf | |
| 12/06/2002 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/22/2003 | SUPPL-60 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18086scs060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018086_s060_TimopticTOC.html | |
| 04/17/2002 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086s058.pdf | |
| 12/05/2001 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2001 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18086S54ltr.pdf | |
| 09/18/2000 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 03/18/1998 | SUPPL-52 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-086S052.pdf |
| 08/05/1997 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1997 | SUPPL-47 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-086S047.pdf |
| 07/18/1996 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1995 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/24/1995 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 02/24/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/09/1993 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/19/1990 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/15/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/28/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/1987 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/29/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1986 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/30/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/27/1981 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/31/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/15/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/13/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/20/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/06/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/02/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/08/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2021 | SUPPL-80 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018086Orig1s080lbl.pdf | |
| 11/17/2021 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018086Orig1s080lbl.pdf | |
| 08/09/2016 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018086s076lbl.pdf | |
| 09/30/2011 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018086s075lbl.pdf | |
| 04/26/2006 | SUPPL-72 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf | |
| 04/26/2006 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018086s070s072lbl.pdf | |
| 12/22/2003 | SUPPL-60 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18086scs060_timoptic_lbl.pdf |
| 04/29/2002 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18086s58lbl.pdf | |
| 04/12/2001 | SUPPL-54 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18086S54lbl.pdf |
TIMOPTIC
SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 077259 | FDC LTD |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 078771 | MANKIND PHARMA |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 217343 | MICRO LABS |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 074746 | PACIFIC PHARMA |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 074261 | SANDOZ |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 217764 | SOMERSET |
| TIMOPTIC | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT1 | 018086 | BAUSCH AND LOMB INC |
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 218460 | CAPLIN |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 077259 | FDC LTD |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 078771 | MANKIND PHARMA |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 217343 | MICRO LABS |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 074747 | PACIFIC PHARMA |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 074262 | SANDOZ |
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 217764 | SOMERSET |
| TIMOPTIC | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT1 | 018086 | BAUSCH AND LOMB INC |