Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207310
Company: FRESENIUS KABI USA

Products on ANDA 207310

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207310

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2017	ORIG-1	Approval		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
08/04/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/19/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/24/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207310

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	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	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