Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074746
Company: PACIFIC PHARMA
Company: PACIFIC 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/25/1997 | 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 |
|---|---|---|---|---|---|
| 04/03/2020 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/14/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/15/2002 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/03/2002 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/08/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/29/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/16/1997 | 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 | 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 |