Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019631
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;110MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;110MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 3.3GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;110MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/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 |
|---|---|---|---|---|---|
| 01/24/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2004 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19631s023ltr.pdf | |
| 07/23/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2002 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/12/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/11/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/1994 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/13/1990 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-2 | Manufacturing (CMC)-Formulation |
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 |
|---|---|---|---|---|---|
| 09/27/2004 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf |
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 2.5GM/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016697 | BAXTER HLTHCARE |
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211190 | FRESENIUS KABI USA |
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;200MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016689 | BAXTER HLTHCARE |
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;330MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;330MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016687 | BAXTER HLTHCARE |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211276 | FRESENIUS KABI USA |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017607 | ICU MEDICAL INC |
| DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016683 | BAXTER HLTHCARE |
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211211 | FRESENIUS KABI USA |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017585 | ICU MEDICAL INC |
| DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016678 | BAXTER HLTHCARE |