Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BLOCADREN | TIMOLOL MALEATE |
| 002 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BLOCADREN | TIMOLOL MALEATE |
| 004 | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BLOCADREN | TIMOLOL MALEATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1981-11-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-03-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 1982-05-07 | |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2009-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-04-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 6 | AP | 1983-07-22 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1982-09-20 | |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2009-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1983-09-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1983-12-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 1990-03-08 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1983-08-29 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1983-08-29 | |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 1985-02-25 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1985-02-25 | |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2009-03-13 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1985-01-02 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1987-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1985-08-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 1987-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1988-08-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1986-08-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 1987-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1987-06-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1989-06-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1991-04-17 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1994-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-04-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-04-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1998-05-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1998-02-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 1998-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2001-12-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 36 | AP | 2003-02-25 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2002-03-27 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 35 | Null | 0 |
CDER Filings
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(
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(
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[companyName] =>
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[labels] =>
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[supplements] =>
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)
)