Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| 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 |
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 |
|---|---|---|---|---|---|
| 05/14/2018 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018564Orig1s062,019345Orig1s047,018562Orig1s059,018563Orig1s060,018561Orig1s060ltr.pdf | |
| 02/22/2016 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018564Orig1s059,019345Orig1s044,018562Org1s056,018563Orig1s057,018561Orig1s057ltr.pdf | |
| 09/11/2003 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/16/1999 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 05/27/1999 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1986 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/25/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | 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 |
|---|---|---|---|---|---|
| 05/14/2018 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf | |
| 02/22/2016 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.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 |