Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088400
Company: FRESENIUS KABI USA
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 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
01/16/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/23/2015 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/21/2007 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

08/08/2007 SUPPL-23 Labeling

Label is not available on this site.

07/12/2002 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/25/2001 SUPPL-20 Labeling

Label is not available on this site.

11/02/1992 SUPPL-19 Labeling

Label is not available on this site.

02/21/1991 SUPPL-18 Labeling

Label is not available on this site.

05/29/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/24/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/19/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/07/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/28/1984 SUPPL-1 Manufacturing (CMC)

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 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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