Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | No | 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 |
---|---|---|---|---|---|---|---|
04/28/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2022 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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11/22/2022 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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04/08/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/21/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
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03/21/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/01/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/28/2002 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/05/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/07/2000 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/28/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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08/27/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1999 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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02/20/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/27/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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08/04/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TIMOLOL MALEATE
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 | 074778 | BAUSCH AND LOMB |
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 |