Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019228
Company: ABRAXIS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANGANESE SULFATE MANGANESE SULFATE EQ 0.1MG MANGANESE/ML 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
05/05/1987 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/25/1994 SUPPL-5 Labeling

Label is not available on this site.

06/09/1992 SUPPL-3 Labeling

Label is not available on this site.

06/07/1989 SUPPL-1 Labeling

Label is not available on this site.

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