Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088912
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 9MG/ML INJECTABLE;INJECTION Prescription AP No 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
01/10/1985 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-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/13/2002 SUPPL-22 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/08/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

02/02/1993 SUPPL-20 Labeling

Label is not available on this site.

11/02/1992 SUPPL-19 Labeling

Label is not available on this site.

08/11/1992 SUPPL-18 Labeling

Label is not available on this site.

11/15/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/15/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/28/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/08/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/29/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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 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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