Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019778
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRINZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/16/1989 | 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 |
|---|---|---|---|---|---|
| 02/26/2013 | SUPPL-49 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019778Orig1s049ltr.pdf | |
| 06/06/2012 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019778s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf | |
| 08/26/2011 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019778s047ltr.pdf | |
| 11/17/2011 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778Orig1s046_REPLACEMENT.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf | |
| 01/28/2011 | SUPPL-45 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf | |
| 06/10/2011 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf |
| 10/09/2008 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf |
| 10/09/2008 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf |
| 02/02/2007 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf |
| 10/18/2006 | SUPPL-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf |
| 06/16/2006 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf |
| 10/05/2005 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019778s036ltr.pdf |
| 03/02/2004 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf |
| 07/02/2002 | SUPPL-34 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19778-S-034_Prinzide_review.pdf |
| 08/23/2001 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2002 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778slr032ltr.pdf |
| 06/09/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 02/17/1999 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf |
| 10/28/1998 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028.cfm | |
| 11/01/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/28/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/08/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 05/30/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/24/1994 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/14/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-14 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 03/10/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/06/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/12/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/30/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/26/2013 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf | |
| 06/06/2012 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019778s048lbl.pdf | |
| 11/17/2011 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778Orig1s046_REPLACEMENT.pdf | |
| 08/26/2011 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s047lbl.pdf | |
| 01/28/2011 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf | |
| 10/28/1998 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_prntlbl.pdf |