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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214414
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
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