Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
11/03/2021 | 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. |
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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. |
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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. |
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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 |
---|---|---|---|---|---|
11/03/2021 | 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 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 | ICU MEDICAL INC |
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 |