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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210799
Company: NOVITIUM PHARMA

Products on ANDA 210799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZOXIDE	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/08/2020	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
08/29/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210799

DIAZOXIDE

SUSPENSION;ORAL; 50MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZOXIDE	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	No	AB	211050	E5 PHARMA INC
DIAZOXIDE	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	No	AB	210799	NOVITIUM PHARMA
PROGLYCEM	DIAZOXIDE	50MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	017453	TEVA BRANDED PHARM

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