Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMOLIDE 10-25 | HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE | 25MG;10MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/11/1981 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/05/2002 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2003 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18061slr029ltr.pdf |
| 05/15/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1998 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/09/1997 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/21/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/01/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1987 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/06/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 10/04/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/18/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/23/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/20/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 02/24/1982 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/13/2009 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |