Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207556
Company: ELYSIUM
Company: ELYSIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
TIMOLOL MALEATE | TIMOLOL MALEATE | 20MG | 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 |
---|---|---|---|---|---|---|---|
05/02/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TIMOLOL MALEATE
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 | 207556 | ELYSIUM |
TIMOLOL MALEATE | TIMOLOL MALEATE | 5MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
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 | 207556 | ELYSIUM |
TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
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 | 207556 | ELYSIUM |
TIMOLOL MALEATE | TIMOLOL MALEATE | 20MG | TABLET;ORAL | Prescription | No | AB | 072668 | MYLAN |
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