Drugs@FDA: FDA-Approved Drugs
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/13/1975 | 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 |
|---|---|---|---|---|---|
| 09/08/2014 | SUPPL-153 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2006 | SUPPL-123 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017607s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017607Orig1s123ltr.pdf | |
| 07/18/2002 | SUPPL-119 | Labeling |
Label is not available on this site. |
||
| 03/31/1999 | SUPPL-118 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-117 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-116 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-115 | Labeling |
Label is not available on this site. |
||
| 03/28/1997 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1996 | SUPPL-113 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1996 | SUPPL-112 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-111 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1996 | SUPPL-110 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-109 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1995 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-104 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-103 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-102 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-100 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1985 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1985 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 05/03/1985 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1985 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1984 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1988 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1984 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1984 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1984 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1984 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1983 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1984 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 10/10/1984 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1984 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1983 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1982 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1982 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/1982 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1982 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1981 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1981 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 10/21/1981 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1981 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1980 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1980 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1980 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/1980 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/10/1979 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1979 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1979 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1979 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1979 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 01/05/1979 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1979 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/08/1978 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1978 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1978 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1979 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1978 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1978 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1978 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1978 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1978 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/30/1978 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1978 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1978 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/10/1978 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/11/1978 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1978 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1977 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1977 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/14/1978 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1976 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/20/1975 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1975 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1975 | 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 |
|---|---|---|---|---|---|
| 04/10/2006 | SUPPL-123 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017607s123lbl.pdf |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211276 | FRESENIUS KABI USA |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019631 | B BRAUN |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017607 | ICU MEDICAL INC |
| DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016683 | BAXTER HLTHCARE |