Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019759
Company: HOSPIRA
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 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
06/08/1988 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
12/01/2016 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019759s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019759Orig1s047ltr.pdf
06/10/2016 SUPPL-46 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019465Orig1s054,019466Orig1s057,019479Orig1s049,019480Orig1s045,019759Orig1s046ltr.pdf
11/01/2002 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/06/2000 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/06/2000 SUPPL-30 Labeling

Label is not available on this site.

04/06/2000 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/01/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/02/1999 SUPPL-25 Labeling

Label is not available on this site.

03/04/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/31/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/24/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/23/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/05/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/25/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/30/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/28/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/16/1993 SUPPL-10 Labeling

Label is not available on this site.

11/02/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/01/1993 SUPPL-8 Labeling

Label is not available on this site.

12/01/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/09/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/18/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/20/1989 SUPPL-2 Labeling

Label is not available on this site.

12/06/1988 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
12/01/2016 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019759s047lbl.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

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