Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLOCADREN | TIMOLOL MALEATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| BLOCADREN | TIMOLOL MALEATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| BLOCADREN | TIMOLOL MALEATE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/25/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2002 | SUPPL-37 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18017s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-017S037.pdf |
| 02/25/2003 | SUPPL-36 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18017slr036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18-017s036_Blocadren.cfm |
| 12/17/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 02/13/1998 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/04/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/09/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 04/17/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 06/05/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/01/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 08/12/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1988 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 08/08/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1987 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/02/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
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| 02/25/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 02/25/1985 | SUPPL-14 | Efficacy |
Label is not available on this site. |
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| 08/29/1983 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/29/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/08/1990 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
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| 12/23/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/23/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-8 | Efficacy-New Indication |
Label is not available on this site. |
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| 09/20/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/22/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/09/1982 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 05/07/1982 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 03/03/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/20/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |