Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019634
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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 |
|---|---|---|---|---|---|---|---|
| 02/24/1988 | 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 |
|---|---|---|---|---|---|
| 11/05/2025 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019632s067,019634s058,020002s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019632Orig1s067,019634Orig1s058,020002Orig1s037ltr.pdf | |
| 11/03/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019632Orig1s050, 019634Orig1s050, 020002Orig1s032ltr.pdf | |
| 02/13/2013 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019634s033ltr.pdf | |
| 08/22/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2004 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19634s021ltr.pdf | |
| 07/23/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/12/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1999 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1990 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1990 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1988 | 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 |
|---|---|---|---|---|---|
| 11/05/2025 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019632s067,019634s058,020002s037lbl.pdf | |
| 11/03/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf | |
| 02/13/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019634s033lbl.pdf | |
| 09/27/2004 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19634s021lbl.pdf |
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND LACTATED RINGER'S | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 210332 | FRESENIUS KABI USA |
| DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017608 | OTSUKA ICU MEDCL |
| DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019634 | B BRAUN |
| LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016679 | BAXTER HLTHCARE |