Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016734
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STERILE WATER IN PLASTIC CONTAINER 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
09/10/1970 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
03/30/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

05/08/2013 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

07/08/2002 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1998 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1990 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/19/1988 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1985 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1985 SUPPL-35 Labeling

Label is not available on this site.

03/05/1987 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1985 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1985 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/1985 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1982 SUPPL-30 Labeling

Label is not available on this site.

09/24/1981 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1981 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1981 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/27/1981 SUPPL-26 Labeling

Label is not available on this site.

10/27/1981 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/16/1980 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1980 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1979 SUPPL-22 Labeling

Label is not available on this site.

09/24/1979 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1981 SUPPL-20 Labeling

Label is not available on this site.

07/20/1979 SUPPL-19 Labeling

Label is not available on this site.

04/26/1979 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1980 SUPPL-17 Labeling

Label is not available on this site.

08/03/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1978 SUPPL-13 Labeling

Label is not available on this site.

12/27/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/19/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1976 SUPPL-7 Labeling

Label is not available on this site.

04/02/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1974 SUPPL-3 Labeling

Label is not available on this site.

STERILE WATER IN PLASTIC CONTAINER

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 No 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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