Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020047
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 50% IN PLASTIC CONTAINER | DEXTROSE | 50GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DEXTROSE 60% IN PLASTIC CONTAINER | DEXTROSE | 60GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/02/1991 | 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 |
|---|---|---|---|---|---|
| 11/10/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2019 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf | |
| 12/22/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf | |
| 07/31/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/24/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/05/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf | |
| 12/22/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf |
DEXTROSE 50% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 50GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 50% IN PLASTIC CONTAINER | DEXTROSE | 50GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020047 | BAXTER HLTHCARE |
| DEXTROSE 50% IN PLASTIC CONTAINER | DEXTROSE | 50GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018563 | ICU MEDICAL INC |
DEXTROSE 60% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 70% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 70GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019626 | B BRAUN |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020047 | BAXTER HLTHCARE |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018561 | ICU MEDICAL INC |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019893 | ICU MEDICAL INC |