Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE | 37MG/100ML;5GM/100ML;30MG/100ML;119MG/100ML;161MG/100ML;94MG/100ML;138MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 08/14/2001 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/01/2001 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 11/24/1999 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/2000 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 04/29/1997 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/18/1994 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1994 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/29/1991 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/26/1991 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/15/1991 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/26/1989 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/25/1987 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/28/1987 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/27/1986 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/15/1985 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/1985 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 06/13/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/28/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/28/1985 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/28/1985 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/16/1982 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/20/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/03/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 12/21/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/29/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/21/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/06/1980 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/30/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/18/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/15/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/10/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/02/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/25/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |