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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208272
Company: TORRENT

Products on ANDA 208272

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Discontinued	None	No	No
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208272

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

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