Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| PLASMA-LYTE A IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/1979 | 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 |
|---|---|---|---|---|---|
| 08/05/2019 | SUPPL-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017378s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017378Orig1s075ltr.pdf | |
| 04/28/2016 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2016 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2013 | SUPPL-68 | 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 | |
| 01/27/2009 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017451s060,017378s065ltr.pdf | |
| 08/14/2001 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-55 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf |
| 04/29/1997 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1985 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/03/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | 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. |
||
| 06/18/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1979 | 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 |
|---|---|---|---|---|---|
| 08/05/2019 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017378s075lbl.pdf | |
| 09/11/2013 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017378s068,017385s059lbl.pdf | |
| 01/27/2009 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017451s060,017378s065lbl.pdf |
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215370 | FRESENIUS KABI USA |
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215371 | FRESENIUS KABI USA |
| PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |
| PLASMA-LYTE A IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |
PLASMA-LYTE A IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215370 | FRESENIUS KABI USA |
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 215371 | FRESENIUS KABI USA |
| PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |
| PLASMA-LYTE A IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017378 | BAXTER HLTHCARE |