Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088911
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION 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
02/07/1985 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
05/21/2007 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/13/1993 SUPPL-11 Labeling

Label is not available on this site.

01/08/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/20/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/30/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/31/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/17/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 9MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 088911 FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 018800 HOSPIRA
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 206171 SPECTRA MDCL DEVICES
SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 201850 WEST-WARD PHARMS INT
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 016677 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 020178 BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 088912 FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 018803 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 019217 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription Yes AP 019465 HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 203352 JUBILANT HOLLISTRSTR
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription No AP 077407 TARO

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