Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017428
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription AT Yes 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
12/31/1974 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
08/04/2016 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

10/17/2017 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017428Orig1s071,017866Orig1s052ltr.pdf
09/28/2011 SUPPL-69 Labeling-Container/Carton Labels

Label is not available on this site.

09/14/1993 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

09/30/1994 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/26/1991 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/14/1991 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

05/18/1990 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

10/30/1986 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

04/06/1985 SUPPL-52 Labeling

Label is not available on this site.

02/28/1984 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/07/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/22/1982 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/22/1982 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/22/1982 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/16/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/10/1981 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/24/1985 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/06/1981 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/29/1981 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/23/1981 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/22/1981 SUPPL-35 Labeling

Label is not available on this site.

04/09/1982 SUPPL-34 Labeling

Label is not available on this site.

04/09/1982 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/31/1980 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/01/1982 SUPPL-31 Labeling

Label is not available on this site.

04/09/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/19/1979 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/02/1980 SUPPL-28 Labeling

Label is not available on this site.

06/02/1980 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/29/1979 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/08/1979 SUPPL-25 Labeling

Label is not available on this site.

03/14/1979 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/14/1979 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/20/1978 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/11/1979 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/11/1979 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/05/1977 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/12/1977 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/12/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/26/1977 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/11/1979 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/20/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/06/1976 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/16/1976 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/17/1976 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/10/1976 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/10/1976 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/06/1976 SUPPL-6 Labeling

Label is not available on this site.

09/02/1976 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/28/1976 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/18/1976 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/07/1975 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/17/2017 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017428s071_017866s052lbl.pdf

STERILE WATER

LIQUID;IRRIGATION; 100%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
STERILE WATER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription Yes AT 017428 BAXTER HLTHCARE
STERILE WATER IN PLASTIC CONTAINER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription Yes AT 016734 B BRAUN
STERILE WATER IN PLASTIC CONTAINER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription No AT 017866 BAXTER HLTHCARE
STERILE WATER IN PLASTIC CONTAINER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription No AT 017513 ICU MEDICAL INC
STERILE WATER IN PLASTIC CONTAINER STERILE WATER FOR IRRIGATION 100% LIQUID;IRRIGATION Prescription No AT 018313 ICU MEDICAL INC

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