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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208257
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROFLUMILAST ROFLUMILAST 500MCG TABLET;ORAL Prescription AB No No
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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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 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 208272 TORRENT
ROFLUMILAST ROFLUMILAST 500MCG TABLET;ORAL Prescription No AB 208303 ZYDUS PHARMS
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