Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016678
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/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
12/09/1970 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
12/23/2015 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

08/22/2019 SUPPL-107 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016678Orig1s107, 016683Orig1s103, 016687Orig1s104, 016689Orig1s107, 016697Orig1s098ltr.pdf
01/12/2015 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

09/10/2013 SUPPL-105 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016678Orig1s105,016697Orig1s096,016689Orig1s05,016696Origs097,016683Orig1s100,016687Orig1s102ltr.pdf
06/02/2004 SUPPL-98 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16678slr098,16687slr095,16696slr092ltr.pdf
08/14/2001 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

11/29/2000 SUPPL-94 Labeling

Label is not available on this site.

04/29/1997 SUPPL-93 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1996 SUPPL-92 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-82 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-78 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1985 SUPPL-76 Labeling

Label is not available on this site.

06/13/1985 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-70 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.

03/16/1984 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1982 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-64 Labeling

Label is not available on this site.

11/20/1981 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1981 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-58 Labeling

Label is not available on this site.

12/21/1981 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1981 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1980 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1980 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1978 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1978 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1978 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1978 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.

02/28/1978 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1977 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1977 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1976 SUPPL-26 Labeling

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.

11/29/1976 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
08/22/2019 SUPPL-107 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf
09/10/2013 SUPPL-105 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016678s105,016697s096,016689s105,016696s097,016683s100,016687s102lbl.pdf

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;900MG/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 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 019631 B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017585 ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER DEXTROSE; SODIUM CHLORIDE 5GM/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 016678 BAXTER HLTHCARE

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