Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER | SODIUM LACTATE | 1.87GM/100ML | 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 |
---|---|---|---|---|---|---|---|
03/22/1971 | 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 |
---|---|---|---|---|---|
01/12/2015 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
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04/26/2013 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
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10/19/2011 | SUPPL-95 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf | |
08/14/2001 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/2000 | SUPPL-87 | Labeling |
Label is not available on this site. |
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11/24/1999 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/2000 | SUPPL-85 | Labeling |
Label is not available on this site. |
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04/29/1997 | SUPPL-84 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/18/1994 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/30/1994 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/26/1991 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/29/1991 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/26/1991 | SUPPL-78 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/1991 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/26/1989 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/25/1987 | SUPPL-75 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/28/1987 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1986 | SUPPL-72 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/15/1985 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/17/1985 | SUPPL-68 | Labeling |
Label is not available on this site. |
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06/13/1985 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/22/1984 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/28/1984 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/28/1985 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/28/1985 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/16/1984 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1985 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/16/1982 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/11/1983 | SUPPL-57 | Labeling |
Label is not available on this site. |
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11/20/1981 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/03/1982 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1982 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/26/1981 | SUPPL-52 | Labeling |
Label is not available on this site. |
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12/21/1981 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/29/1981 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/21/1981 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/31/1980 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/16/1981 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/30/1980 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/07/1980 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/28/1980 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/02/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/20/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/07/1978 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/02/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/25/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
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03/22/1978 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1980 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/20/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/24/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/28/1978 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/14/1977 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/06/1977 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/07/1977 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/13/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
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06/17/1976 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1976 | SUPPL-21 | Labeling |
Label is not available on this site. |
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01/05/1976 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/18/1976 | SUPPL-18 | Labeling |
Label is not available on this site. |
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09/23/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/11/1976 | SUPPL-16 | Labeling |
Label is not available on this site. |
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09/17/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/25/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/10/1975 | SUPPL-12 | 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 |
---|---|---|---|---|---|
10/19/2011 | SUPPL-95 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf |