Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/05/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
04/06/2017 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019463s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019463Orig1s031ltr.pdf | |
08/14/2015 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/30/2011 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019463s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019463s028ltr.pdf | |
06/05/2006 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019463s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019463s027LTR.pdf | |
12/22/2003 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19463slr026_timoptic_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19463slr026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019463_s026_TimopticTOC.cfm | |
07/26/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/04/2001 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/07/2001 | SUPPL-22 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19463s22lbl.pdf | |
03/02/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/02/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
03/18/1998 | SUPPL-19 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-463S019.pdf |
06/22/1997 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/14/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/02/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/02/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/22/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/16/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
07/10/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/18/1995 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
12/09/1993 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
03/25/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/21/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/21/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
07/09/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/09/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |
TIMOPTIC IN OCUDOSE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT3
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 | AT3 | 212592 | AMRING PHARMS |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT3 | 216533 | INGENUS PHARMS LLC |
TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT3 | 019463 | BAUSCH AND LOMB INC |
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT3
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 | AT3 | 212291 | AKORN |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT3 | 212592 | AMRING PHARMS |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT3 | 216533 | INGENUS PHARMS LLC |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT3 | 216596 | MICRO LABS |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT3 | 217195 | SENTISS PHARMA |
TIMOPTIC IN OCUDOSE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT3 | 019463 | BAUSCH AND LOMB INC |