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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088911
Company: FRESENIUS KABI USA

Products on ANDA 088911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1985	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-14	Manufacturing (CMC)-Facility		Label is not available on this site.
01/13/1993	SUPPL-11	Labeling		Label is not available on this site.
01/08/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/20/2001	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/30/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/31/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/17/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/17/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088911

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SOLUTION;INJECTION; 270MG/30ML (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	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088911	FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018800	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	270MG/30ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088912	FRESENIUS KABI USA

SOLUTION;INJECTION; 90MG/10ML (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	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088911	FRESENIUS KABI USA
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018800	HOSPIRA
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	201833	HIKMA
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	217535	NEXUS PHARMS
SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	206171	SPECTRA MDCL DEVICES
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	088912	FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	Yes	AP	018803	HOSPIRA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION;INJECTION	Prescription	No	AP	077407	TARO

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