Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019635
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 900MG/10ML INJECTABLE;INJECTION Prescription None Yes No
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE 3GM/100ML INJECTABLE;INJECTION Prescription AP No No
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE 5GM/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
03/09/1988 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
04/26/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/15/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

07/20/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/08/2014 SUPPL-35 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf
02/04/2004 SUPPL-23 Labeling

Label is not available on this site.

02/04/2004 SUPPL-22 Labeling

Label is not available on this site.

06/13/2003 SUPPL-21 Labeling

Label is not available on this site.

07/01/2002 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/2002 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2000 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/15/2000 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/21/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/07/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/26/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/21/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/29/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/29/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/18/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/13/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/05/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/21/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/21/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/25/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/04/1988 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
09/08/2014 SUPPL-35 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019635 B BRAUN
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 018016 BAXTER HLTHCARE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 208122 FRESENIUS KABI USA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription No AP 019759 HOSPIRA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 018090 ICU MEDICAL INC

SODIUM CHLORIDE 0.9%

There are no Therapeutic Equivalents.

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;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 INJECTABLE;INJECTION Prescription Yes AP 017464 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019635 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016677 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020178 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207310 FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 078177 FRESENIUS MEDCL
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 076316 HAEMONETICS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019465 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019480 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016366 ICU MEDICAL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207956 LABORATORIOS GRIFOLS

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 3GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE 3GM/100ML INJECTABLE;INJECTION Prescription No AP 019635 B BRAUN
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER SODIUM CHLORIDE 3GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019022 BAXTER HLTHCARE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE 5GM/100ML INJECTABLE;INJECTION Prescription No AP 019635 B BRAUN
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER SODIUM CHLORIDE 5GM/100ML INJECTABLE;INJECTION Prescription Yes AP 019022 BAXTER HLTHCARE

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