U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208256
Company: MSN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROFLUMILAST ROFLUMILAST 250MCG TABLET;ORAL Prescription AB No No
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
09/07/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208256Orig1s000ltr.pdf

ROFLUMILAST

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 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

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
Back to Top