Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211135
Company: MSN
Company: MSN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RIOCIGUAT | RIOCIGUAT | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
RIOCIGUAT | RIOCIGUAT | 1MG | TABLET;ORAL | Prescription | AB | No | No |
RIOCIGUAT | RIOCIGUAT | 1.5MG | TABLET;ORAL | Prescription | AB | No | No |
RIOCIGUAT | RIOCIGUAT | 2MG | TABLET;ORAL | Prescription | AB | No | No |
RIOCIGUAT | RIOCIGUAT | 2.5MG | 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 |
---|---|---|---|---|---|---|---|
09/01/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211135Orig1s000ltr.pdf |
RIOCIGUAT
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADEMPAS | RIOCIGUAT | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 204819 | BAYER HLTHCARE |
RIOCIGUAT | RIOCIGUAT | 0.5MG | TABLET;ORAL | Prescription | No | AB | 211135 | MSN |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADEMPAS | RIOCIGUAT | 1MG | TABLET;ORAL | Prescription | Yes | AB | 204819 | BAYER HLTHCARE |
RIOCIGUAT | RIOCIGUAT | 1MG | TABLET;ORAL | Prescription | No | AB | 211135 | MSN |
TABLET;ORAL; 1.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADEMPAS | RIOCIGUAT | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 204819 | BAYER HLTHCARE |
RIOCIGUAT | RIOCIGUAT | 1.5MG | TABLET;ORAL | Prescription | No | AB | 211135 | MSN |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADEMPAS | RIOCIGUAT | 2MG | TABLET;ORAL | Prescription | Yes | AB | 204819 | BAYER HLTHCARE |
RIOCIGUAT | RIOCIGUAT | 2MG | TABLET;ORAL | Prescription | No | AB | 211135 | MSN |
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ADEMPAS | RIOCIGUAT | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 204819 | BAYER HLTHCARE |
RIOCIGUAT | RIOCIGUAT | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211135 | MSN |