Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214414
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | AB | No | No |
SELEXIPAG | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | AB | No | No |
SELEXIPAG | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | AB | No | No |
SELEXIPAG | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | AB | No | No |
SELEXIPAG | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | AB | No | No |
SELEXIPAG | SELEXIPAG | 1.6MG | 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 |
---|---|---|---|---|---|---|---|
10/11/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214414Orig1s000ltr.pdf |
SELEXIPAG
TABLET;ORAL; 0.2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.2MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.4MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.6MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 0.8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 0.8MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1.4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 1.4MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |
TABLET;ORAL; 1.6MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SELEXIPAG | SELEXIPAG | 1.6MG | TABLET;ORAL | Prescription | No | AB | 214414 | ALEMBIC |
UPTRAVI | SELEXIPAG | 1.6MG | TABLET;ORAL | Prescription | Yes | AB | 207947 | ACTELION |