Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018962
Company: HOSPIRA
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 |