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Drugs@FDA: FDA-Approved Drugs

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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HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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HYDROCHLOROTHIAZIDE; LISINOPRIL 25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

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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