Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018233
Company: ICU MEDICAL INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/18/1980 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
09/05/2013 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

11/02/2007 SUPPL-68 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018233s068ltr.pdf
01/19/2005 SUPPL-63 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18233s063ltr.pdf
01/24/2003 SUPPL-62 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18233scs062ltr.pdf
10/15/2002 SUPPL-61 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/04/1999 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1998 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1997 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

06/14/2000 SUPPL-57 Labeling

Label is not available on this site.

08/06/1996 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1996 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1996 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1995 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1991 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1992 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/10/1991 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1986 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1985 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1986 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-34 Labeling

Label is not available on this site.

05/03/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1985 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1984 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1985 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1985 SUPPL-26 Labeling

Label is not available on this site.

11/29/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1985 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/09/1984 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1983 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/17/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1984 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1983 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1984 SUPPL-18 Labeling

Label is not available on this site.

10/10/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1981 SUPPL-9 Labeling

Label is not available on this site.

03/12/1982 SUPPL-8 Labeling

Label is not available on this site.

03/02/1981 SUPPL-7 Labeling

Label is not available on this site.

03/02/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1980 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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 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 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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