Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208256
Company: MSN
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 |