Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019778
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HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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

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