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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200480
Company: SEPTODONT

Products on ANDA 200480

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DYCLOPRO	DYCLONINE HYDROCHLORIDE	0.5%	SOLUTION;TOPICAL	Prescription	None	No	Yes
DYCLOPRO	DYCLONINE HYDROCHLORIDE	1%	SOLUTION;TOPICAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200480

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2018	ORIG-1	Approval	Not Applicable			Label is not available on this site.

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