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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208247
Company: STRIDES PHARMA

Products on ANDA 208247

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROFLUMILAST	ROFLUMILAST	500MCG	TABLET;ORAL	Prescription	AB	No	No
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208247

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2020	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
04/13/2023	SUPPL-2	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208247

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	NORVIUM BIOSCIENCE
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

TABLET;ORAL; 250MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DALIRESP	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	Yes	AB	022522	ASTRAZENECA
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	212490	ALKEM LABS LTD
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	213298	AUROBINDO PHARMA LTD
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208213	HETERO LABS LTD III
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208180	MICRO LABS
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208256	MSN
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208247	STRIDES PHARMA
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208272	TORRENT
ROFLUMILAST	ROFLUMILAST	250MCG	TABLET;ORAL	Prescription	No	AB	208303	ZYDUS PHARMS

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