Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005619
Company: MERCK
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
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.

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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