Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214645
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | AB | No | No |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
06/24/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AB
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, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 212942 | ALEMBIC |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 215733 | DR REDDYS |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 214645 | GLAND PHARMA LTD |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020963 | SANDOZ |
TIMOPTIC-XE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020330 | BAUSCH AND LOMB INC |
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AB
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, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 212942 | ALEMBIC |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 215733 | DR REDDYS |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 213540 | EUGIA PHARMA |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | No | AB | 214645 | GLAND PHARMA LTD |
TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020963 | SANDOZ |
TIMOPTIC-XE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020330 | BAUSCH AND LOMB INC |