An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208213
Company: HETERO LABS LTD III

Products on ANDA 208213

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 208213

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208213Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2023	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208213

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

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	208236	BRECKENRIDGE
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	208303	ZYDUS PHARMS

Top