Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018008
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/1979 | 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 |
|---|---|---|---|---|---|
| 02/21/2019 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018008Orig1s073,018037Orig1s073,018629Orig1s046,019308Orig1s030ltr.pdf | |
| 09/26/2014 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2013 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf | |
| 04/20/2007 | SUPPL-66 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf | |
| 08/26/2005 | SUPPL-65 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf | |
| 06/02/2004 | SUPPL-63 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf |
| 08/14/2001 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2003 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf |
| 11/24/1999 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1993 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1984 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 04/28/1982 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-8 | 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 |
|---|---|---|---|---|---|
| 02/21/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf | |
| 09/10/2013 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf | |
| 04/20/2007 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf | |
| 08/26/2005 | SUPPL-65 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 213523 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018362 | ICU MEDICAL INC |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018008 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.