Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| 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 |
|---|---|---|---|---|---|---|---|
| 01/25/1971 | 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 |
|---|---|---|---|---|---|
| 08/12/2020 | SUPPL-127 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/016694Orig1s127ltr.pdf |
| 01/15/2016 | SUPPL-123 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/2019 | SUPPL-121 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016673Orig1s149, 016694Orig1s121, 020047Orig1s021, 020179Orig1s012ltr.pdf | |
| 05/23/2014 | SUPPL-120 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2014 | SUPPL-119 | 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 | |
| 07/10/2006 | SUPPL-113 | Labeling |
Label is not available on this site. |
||
| 02/04/2005 | SUPPL-108 | Labeling |
Label is not available on this site. |
||
| 05/15/2003 | SUPPL-107 | Labeling |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-105 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-104 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-103 | Labeling |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-102 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-100 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1999 | SUPPL-98 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1994 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1990 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1985 | SUPPL-82 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1984 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1984 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 06/07/1984 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1982 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 03/23/1982 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1980 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1980 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1980 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 03/18/1980 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1980 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1978 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1978 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1978 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/22/1978 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1980 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1978 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1978 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1977 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1977 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1976 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 06/17/1976 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/01/1976 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1976 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/23/1975 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1976 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/17/1975 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1975 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1975 | SUPPL-13 | 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-121 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf | |
| 12/22/2014 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.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 | ICU MEDICAL INC |