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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202981
Company: HOSPIRA

Products on ANDA 202981

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM BICARBONATE	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2016	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202981

SODIUM BICARBONATE

SOLUTION;INTRAVENOUS; 2.5MEQ/5ML (0.5MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM BICARBONATE	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206688	FRESENIUS KABI USA
SODIUM BICARBONATE	SODIUM BICARBONATE	2.5MEQ/5ML (0.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	202981	HOSPIRA

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