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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005619
Company: MERCK

Products on NDA 005619

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOHIPPURATE SODIUM	AMINOHIPPURATE SODIUM	20%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 005619

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1944	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2013	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
06/07/2013	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/18/2011	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/005619s021ltr.pdf
06/03/2005	SUPPL-20	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/005619s020ltr.pdf
11/26/2002	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619slr018ltr.pdf
10/08/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/2001	SUPPL-16	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/05619s16ltr.pdf
11/02/1999	SUPPL-15	Labeling		Label is not available on this site.
01/05/1998	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1996	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
02/13/1987	SUPPL-12	Labeling		Label is not available on this site.
09/01/1982	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/13/1987	SUPPL-10	Labeling		Label is not available on this site.
02/13/1987	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1981	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/08/1981	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/07/1977	SUPPL-6	Labeling		Label is not available on this site.
08/10/1973	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/1973	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 005619

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005619s021lbl.pdf

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