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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208257
Company: MYLAN

Products on ANDA 208257

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208257Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2021	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208257

ROFLUMILAST

TABLET;ORAL; 500MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DALIRESP	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	Yes	AB	022522	ASTRAZENECA
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	212490	ALKEM LABS LTD
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	213298	AUROBINDO PHARMA LTD
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208213	HETERO LABS LTD III
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208180	MICRO LABS
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208256	MSN
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208257	MYLAN
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208299	PRINSTON INC
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208247	STRIDES PHARMA
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	No	AB	208303	ZYDUS PHARMS

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