Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017464
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION 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
02/08/1978 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
10/16/2006 SUPPL-47 Labeling

Label is not available on this site.

02/13/2004 SUPPL-45 Labeling

Label is not available on this site.

05/29/2003 SUPPL-43 Labeling

Label is not available on this site.

06/23/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

08/08/1995 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/02/1991 SUPPL-39 Labeling

Label is not available on this site.

12/31/1991 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/11/1990 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

03/09/1989 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/24/1986 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-31 Labeling

Label is not available on this site.

09/16/1985 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/16/1984 SUPPL-29 Labeling

Label is not available on this site.

10/17/1984 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/09/1984 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/15/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/30/1983 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/21/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/05/1982 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/13/1982 SUPPL-17 Labeling

Label is not available on this site.

10/26/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/24/1983 SUPPL-14 Labeling

Label is not available on this site.

09/30/1981 SUPPL-13 Labeling

Label is not available on this site.

09/30/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/24/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/06/1980 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/16/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/12/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/09/1979 SUPPL-7 Labeling

Label is not available on this site.

10/16/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/08/1979 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/26/1978 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/29/1978 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/29/1978 SUPPL-2 Labeling

Label is not available on this site.

03/23/1978 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 900MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017464 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019635 B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016677 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020178 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207310 FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 078177 FRESENIUS MEDCL
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 076316 HAEMONETICS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019465 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 019480 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 016366 ICU MEDICAL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE;INJECTION Prescription No AP 207956 LABORATORIOS GRIFOLS

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