Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018800
Company: HOSPIRA
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 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
10/29/1982 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
01/06/2017 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/12/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/12/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/19/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18800slr014ltr.pdf
09/30/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2003 SUPPL-11 Labeling

Label is not available on this site.

08/29/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1985 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/25/1984 SUPPL-1 Manufacturing (CMC)-Control

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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