Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/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 |
|---|---|---|---|---|---|---|---|
| 03/22/1971 | 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 |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-114 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016679s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016682Orig1s117,%20019367Orig1s036,%20016679Orig1s114ltr.pdf | |
| 01/19/2016 | SUPPL-111 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-110 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-109 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2017 | SUPPL-108 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016679s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016679s108ltr.pdf | |
| 04/26/2013 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/2013 | SUPPL-106 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/2011 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf | |
| 05/12/2004 | SUPPL-96 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16679slr096ltr.pdf |
| 08/14/2001 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-93 | Labeling |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/2000 | SUPPL-91 | Labeling |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-90 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-89 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-87 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1991 | SUPPL-83 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-81 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-80 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-77 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-71 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1981 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1980 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1980 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1978 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1978 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1978 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/22/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1980 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/20/1978 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1978 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1977 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1977 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1977 | SUPPL-26 | Manufacturing (CMC)-Packaging |
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)-Control |
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)-Control |
Label is not available on this site. |
||
| 01/05/1976 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/23/1975 | SUPPL-18 | Manufacturing (CMC)-Control |
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)-Control |
Label is not available on this site. |
||
| 09/25/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-114 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016679s114lbl.pdf | |
| 12/06/2017 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016679s108lbl.pdf | |
| 10/19/2011 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf |
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017608 | ICU MEDICAL INC |
| DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019634 | B BRAUN |
| LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016679 | BAXTER HLTHCARE |