Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207956
Company: LABORATORIOS GRIFOLS
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 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
05/25/2017 ORIG-1 Approval STANDARD

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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