An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020178
Company: BAXTER HLTHCARE

Products on NDA 020178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;INJECTION	Prescription	AP	Yes	Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020178

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/1992	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
12/07/2022	SUPPL-31	Labeling-Patient Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020178Orig1s031ltr;020179Orig1s026ltr.pdf
01/27/2020	SUPPL-23	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020178Orig1s023ltr.pdf
05/29/2019	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016677s169,018016s067,020178s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016677Orig1s169, 018016Orig1s067, 020178Orig1s021ltr.pdf
07/28/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/23/2015	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020178s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020178Orig1s013ltr.pdf
05/04/2001	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/14/1999	SUPPL-5	Labeling		Label is not available on this site.
12/29/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/15/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/18/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020178

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/29/2019	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016677s169,018016s067,020178s021lbl.pdf
11/23/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020178s013lbl.pdf

Therapeutic Equivalents for NDA 020178

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SOLUTION;INJECTION; 900MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;INJECTION	Prescription	Yes	AP	016677	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;INJECTION	Prescription	Yes	AP	020178	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;INJECTION	Prescription	Yes	AP	019465	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;INJECTION	Prescription	No	AP	211968	NEPHRON

SOLUTION;INJECTION; 450MG/50ML (9MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	016677	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	020178	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018803	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	019465	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	211968	NEPHRON

Top