Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018629
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription AP No No
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/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
03/23/1982 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
07/11/2018 SUPPL-48 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf
02/21/2019 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018008Orig1s073,018037Orig1s073,018629Orig1s046,019308Orig1s030ltr.pdf
07/10/2006 SUPPL-39 Labeling

Label is not available on this site.

03/15/2004 SUPPL-34 Labeling

Label is not available on this site.

08/29/2001 SUPPL-31 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/28/2001 SUPPL-30 Labeling

Label is not available on this site.

01/28/2000 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/11/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/29/1991 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/25/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/28/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/03/1985 SUPPL-13 Labeling

Label is not available on this site.

06/13/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/23/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/28/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/11/1983 SUPPL-9 Labeling

Label is not available on this site.

01/24/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/28/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/16/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/25/1982 SUPPL-2 Labeling

Label is not available on this site.

05/07/1982 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2019 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18008s073,18037s073,18629s046,19308s030lbl.pdf

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;150MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;224MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;224MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;300MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML;330MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 018629 BAXTER HLTHCARE
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5GM/100ML;75MG/100ML;330MG/100ML INJECTABLE;INJECTION Prescription No AP 019630 B BRAUN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English