Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | SOLUTION;IRRIGATION | 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 |
---|---|---|---|---|---|---|---|
03/10/1975 | 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 |
---|---|---|---|---|---|
04/07/2004 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17670slr043ltr.pdf |
02/04/1998 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/27/1996 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/30/1992 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/24/1993 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/25/1988 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/29/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/18/1986 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/25/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1986 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/15/1984 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/01/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/10/1982 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/06/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/31/1982 | SUPPL-25 | Labeling |
Label is not available on this site. |
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10/21/1980 | SUPPL-24 | Labeling |
Label is not available on this site. |
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06/06/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/06/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/23/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/28/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
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07/21/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/20/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/12/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/04/1979 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/31/1979 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/18/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/05/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/30/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/26/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/21/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/20/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
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01/30/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/07/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/19/1976 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |