Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206171
Company: SPECTRA MDCL DEVICES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM CHLORIDE 0.9% 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
07/21/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

SODIUM CHLORIDE 0.9%

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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