Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214805
Company: MILLA PHARMS

Products on ANDA 214805

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM ACETATE	SODIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
SODIUM ACETATE	SODIUM ACETATE	4MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214805

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214805Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214805

SODIUM ACETATE

INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	214805	MILLA PHARMS

INJECTABLE;INJECTION; 4MEQ/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	4MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	206687	FRESENIUS KABI USA
SODIUM ACETATE	SODIUM ACETATE	4MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	214805	MILLA PHARMS