Drugs@FDA: FDA-Approved Drugs
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MODURETIC 5-50 | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/05/1981 | 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 |
|---|---|---|---|---|---|
| 02/25/2003 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18200slr026,18201slr040ltr.pdf |
| 06/24/2002 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2002 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18200s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200s024_Midamor.cfm | |
| 09/18/2001 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1998 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 11/29/1995 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1993 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/01/1992 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/17/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/26/1992 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1991 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1987 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/01/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1986 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/05/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/10/1985 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/16/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/07/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/28/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/19/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/04/1984 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/23/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/04/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/21/2002 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf |