Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018962
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANGANESE CHLORIDE IN PLASTIC CONTAINER MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/26/1986 ORIG-1 Approval 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
06/12/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/06/2002 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18962slr011ltr.pdf
02/16/2001 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/31/1999 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18962slr007ltr.pdf
08/29/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1997 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/29/1987 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/06/2002 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18962slr011lbl.pdf

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