Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020410
Company: AMAG PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GASTROMARK FERUMOXSIL EQ 0.175MG IRON/ML SUSPENSION;ORAL 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
12/06/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/30/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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