Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009509
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARAMINE METARAMINOL BITARTRATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/29/1954 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2001 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/09/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/05/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/15/1992 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1987 SUPPL-19 Labeling

Label is not available on this site.

08/27/1985 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1987 SUPPL-15 Labeling

Label is not available on this site.

10/22/1982 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1981 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/05/1980 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1978 SUPPL-10 Labeling

Label is not available on this site.

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