Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018632
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription AP Yes Yes
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A 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
06/30/1982 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
05/26/2016 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018632Orig1s051ltr.pdf
09/26/2014 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/10/2006 SUPPL-43 Labeling

Label is not available on this site.

05/11/2005 SUPPL-40 Labeling

Label is not available on this site.

01/23/2004 SUPPL-34 Labeling

Label is not available on this site.

08/29/2001 SUPPL-33 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/28/2000 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1999 SUPPL-31 Labeling

Label is not available on this site.

07/28/1998 SUPPL-30 Labeling

Label is not available on this site.

07/15/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

02/07/1995 SUPPL-27 Labeling

Label is not available on this site.

02/18/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/08/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/11/1992 SUPPL-21 Labeling

Label is not available on this site.

05/18/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/19/1988 SUPPL-16 Labeling

Label is not available on this site.

07/25/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/16/1987 SUPPL-13 Labeling

Label is not available on this site.

11/16/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/28/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/09/1986 SUPPL-10 Labeling

Label is not available on this site.

09/09/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/27/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/26/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/26/1985 SUPPL-6 Labeling

Label is not available on this site.

06/13/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/22/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/28/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/14/1984 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

LIQUID;N/A; 100%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018802 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 209689 FRESENIUS KABI USA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 206369 WEST-WARD PHARMS INT
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019633 B BRAUN
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018632 BAXTER HLTHCARE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 088400 FRESENIUS KABI USA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018233 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019869 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 077393 TARO

LIQUID;N/A; 100%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018802 HOSPIRA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 209689 FRESENIUS KABI USA
STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 206369 WEST-WARD PHARMS INT
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019633 B BRAUN
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018632 BAXTER HLTHCARE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 088400 FRESENIUS KABI USA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018801 HOSPIRA
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 018233 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription Yes AP 019869 ICU MEDICAL INC
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER STERILE WATER FOR INJECTION 100% LIQUID;N/A Prescription No AP 077393 TARO

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