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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212458
Company: PADAGIS ISRAEL

Products on ANDA 212458

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212458

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212458Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212458

CYANOCOBALAMIN

SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	210629	LUPIN
CYANOCOBALAMIN	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	212458	PADAGIS ISRAEL
NASCOBAL	CYANOCOBALAMIN	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	021642	ENDO OPERATIONS

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