Drugs@FDA: FDA-Approved Drugs
Company: OTSUKA ICU MEDCL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/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 |
|---|---|---|---|---|---|---|---|
| 08/28/1979 | 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 |
|---|---|---|---|---|---|
| 06/09/2025 | SUPPL-122 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016367s231,018080s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/016367Orig1s231,018080Orig1s122ltr.pdf | |
| 09/08/2014 | SUPPL-115 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/2008 | SUPPL-99 | Labeling |
Label is not available on this site. |
||
| 04/24/2003 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-82 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 03/31/1999 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1984 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1984 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1984 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1986 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/25/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 10/05/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/05/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1980 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1980 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1980 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/07/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/10/1979 | 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 |
|---|---|---|---|---|---|
| 06/09/2025 | SUPPL-122 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016367s231,018080s122lbl.pdf |
DEXTROSE 10% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019626 | B BRAUN |
| DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016694 | BAXTER HLTHCARE |
| DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 209448 | FRESENIUS KABI USA |
| DEXTROSE 10% IN PLASTIC CONTAINER | DEXTROSE | 10GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018080 | OTSUKA ICU MEDCL |