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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218783
Company: RISING

Products on ANDA 218783

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218783

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218783

DICHLORPHENAMIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICHLORPHENAMIDE	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	218783	RISING
KEVEYIS	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	011366	XERIS
ORMALVI	DICHLORPHENAMIDE	50MG	TABLET;ORAL	Prescription	No	AB	215924	TORRENT

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