Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 20MG | TABLET;ORAL | Prescription | AB | No | Yes |
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/08/1990 | 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 |
---|---|---|---|---|---|
08/14/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
06/06/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
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01/17/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
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10/01/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/23/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/06/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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11/16/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/14/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/10/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
07/10/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TIMOLOL MALEATE
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
TIMOLOL MALEATE | TIMOLOL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 207556 | RISING |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 207556 | RISING |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 207556 | RISING |