Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016677
Company: BAXTER HLTHCARE
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 INJECTABLE;INJECTION Prescription AP Yes Yes
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
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
05/29/2019 SUPPL-169 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
03/09/2018 SUPPL-160 Manufacturing (CMC)-Facility Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016677s160lbl.pdf
03/03/2016 SUPPL-151 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016677s151lbl.pdf
05/13/2015 SUPPL-150 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf
06/05/2014 SUPPL-149 Manufacturing (CMC)

Label is not available on this site.

12/22/2014 SUPPL-148 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf
09/11/2013 SUPPL-147 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016677s147,018016s061,016693s096ltr.pdf
08/26/2005 SUPPL-139 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf
05/23/2005 SUPPL-137 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016677s137lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/016677s137ltr.pdf
07/17/2003 SUPPL-131 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16677scs131ltr.pdf
09/16/2002 SUPPL-128 Manufacturing (CMC)

Label is not available on this site.

08/14/2001 SUPPL-126 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-125 Manufacturing (CMC)

Label is not available on this site.

04/03/2002 SUPPL-124 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf
12/31/1997 SUPPL-123 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-122 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/1997 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-120 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/14/1996 SUPPL-119 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/1995 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-117 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-116 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1993 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

06/01/1993 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-109 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1990 SUPPL-108 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1990 SUPPL-107 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-106 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-105 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1988 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-102 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1987 SUPPL-101 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/25/1987 SUPPL-100 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1986 SUPPL-96 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1985 SUPPL-94 Labeling

Label is not available on this site.

06/13/1985 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1985 SUPPL-89 Labeling

Label is not available on this site.

10/30/1985 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1984 SUPPL-87 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/28/1984 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-80 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1982 SUPPL-77 Labeling

Label is not available on this site.

02/16/1982 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-75 Labeling

Label is not available on this site.

11/20/1981 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1981 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-69 Labeling

Label is not available on this site.

12/21/1981 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1981 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1981 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1981 SUPPL-61 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1981 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1980 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1979 SUPPL-50 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/08/1978 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1978 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1978 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1978 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1978 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1978 SUPPL-43 Labeling

Label is not available on this site.

03/22/1978 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1980 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1978 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1977 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1977 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/1978 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1978 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1976 SUPPL-32 Labeling

Label is not available on this site.

07/13/1976 SUPPL-31 Labeling

Label is not available on this site.

01/11/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1976 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1976 SUPPL-26 Labeling

Label is not available on this site.

07/01/1976 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1976 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1976 SUPPL-22 Labeling

Label is not available on this site.

09/23/1975 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1976 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1975 SUPPL-16 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
05/29/2019 SUPPL-169 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016677s169,018016s067,020178s021lbl.pdf
03/09/2018 SUPPL-160 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016677s160lbl.pdf
03/03/2016 SUPPL-151 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016677s151lbl.pdf
05/13/2015 SUPPL-150 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016677s150lbl.pdf
12/22/2014 SUPPL-148 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf
09/11/2013 SUPPL-147 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016677s147,016693s096,018016s061lbl.pdf
08/26/2005 SUPPL-139 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
05/23/2005 SUPPL-137 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016677s137lbl.pdf

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

INJECTABLE;INJECTION; 9MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 088911 FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 018800 HOSPIRA
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 206171 SPECTRA MDCL DEVICES
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 201850 WEST-WARD PHARMS INT
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 016677 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 020178 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 088912 FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 018803 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 019465 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 203352 JUBILANT CADISTA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 077407 TARO

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