Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078771
Company: MANKIND PHARMA
Company: MANKIND PHARMA
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 | No |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | 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 |
---|---|---|---|---|---|---|---|
09/28/2009 | ORIG-1 | Approval |
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 |
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 | 074776 | BAUSCH AND LOMB |
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 |