Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE | 5GM/100ML;32MG/100ML;128MG/100ML;234MG/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 |
---|---|---|---|---|---|---|---|
02/01/1979 | 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 |
---|---|---|---|---|---|
07/11/2018 | SUPPL-64 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf | |
03/18/2016 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017385Orig1s062ltr.pdf | |
12/22/2014 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017385Orig1s060ltr.pdf | |
09/11/2013 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017378Orig1s068,017385Orig1s059ltr.pdf | |
08/14/2001 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/01/2001 | SUPPL-51 | Labeling |
Label is not available on this site. |
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11/24/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/2000 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
04/29/1997 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/18/1994 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1994 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/29/1991 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/10/1991 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/26/1991 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/1991 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/1989 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/25/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/28/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/27/1986 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/15/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/18/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
06/13/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/22/1984 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/28/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/28/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/16/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/24/1985 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/16/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/11/1983 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/20/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/03/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/26/1981 | SUPPL-18 | Labeling |
Label is not available on this site. |
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12/21/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/29/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/21/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/31/1980 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/06/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/16/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/30/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/18/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/10/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/07/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/02/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/25/1980 | 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 |
---|---|---|---|---|---|
03/18/2016 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017385s062lbl.pdf | |
12/22/2014 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017385s060lbl.pdf | |
09/11/2013 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf |