Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 001546
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GUANIDINE HYDROCHLORIDE GUANIDINE HYDROCHLORIDE 125MG TABLET;ORAL Prescription 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
10/02/1939 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
08/03/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/16/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/14/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/28/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/24/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/1546s011.pdf
12/11/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/02/1983 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/16/1980 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/16/1978 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/23/1976 SUPPL-5 Labeling

Label is not available on this site.

01/29/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

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