Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018629
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/23/1982 | 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-48 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf | |
| 02/21/2019 | SUPPL-46 | 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 | |
| 07/10/2006 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/15/2004 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-31 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-1 | Labeling |
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-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;224MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;300MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018629 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 5GM/100ML;75MG/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019630 | B BRAUN |