Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018961
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHROMIC CHLORIDE IN PLASTIC CONTAINER | CHROMIC CHLORIDE | EQ 0.004MG CHROMIUM/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 | Type 5 - New Formulation or New Manufacturer | 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. |
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04/24/2002 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18961s012.pdf | |
02/16/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/31/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/09/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/22/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/29/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/17/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/10/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/29/1987 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
04/24/2002 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18961s12lbl.pdf |