Approvals (Drugs@FDA)

OPSYNVI

ACTELION · MACITENTAN, TADALAFIL

NDA218490Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218490
Sponsor name
ACTELION
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20241212
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      80567
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204410Orig1s030;218490Orig1s001ltr.pdf
      Date
      20241213
      Type
      Letter
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240322
    Review priority
    STANDARD
    Submission class code
    TYPE 4
    Submission class code description
    Type 4 - New Combination
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      77953
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218490Orig1s000ltr.pdf
      Date
      20240325
      Type
      Letter
    2. ID
      77957
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf
      Date
      20240325
      Type
      Label
    3. ID
      77958
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf#page=32
      Date
      20240325
      Type
      Medication Guide
    4. ID
      79983
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218490Orig1s000TOC.html
      Date
      20241025
      Type
      Review
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250402
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      81822
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218490s002lbl.pdf
      Date
      20250403
      Type
      Label
    2. ID
      81891
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204410Orig1s031; 218490Orig1s002ltr.pdf
      Date
      20250408
      Type
      Letter
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    OPSYNVI
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      MACITENTAN
      Strength
      10MG
    2. Name
      TADALAFIL
      Strength
      40MG
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    OPSYNVI
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      MACITENTAN
      Strength
      10MG
    2. Name
      TADALAFIL
      Strength
      20MG
Harmonized identifiers (openFDA)
Application number
NDA218490
Brand name
OPSYNVI
Generic name
MACITENTAN AND TADALAFIL
Manufacturer name
Actelion Pharmaceuticals US, Inc.
Product NDC
66215-812, 66215-814
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
MACITENTAN, TADALAFIL
RxCUI
2677765, 2677771, 2677773, 2677775
SPL ID
32840e17-39b6-50b2-e063-6394a90a7a37
SPL set ID
6945b183-18d3-40de-afd1-c88e33cc1a63
Package NDC
66215-814-30, 66215-814-01, 66215-814-10, 66215-812-07, 66215-812-30, 66215-812-01, 66215-812-08
Nui
N0000175581, N0000175364, N0000175599, N0000020026
Pharm class epc
Endothelin Receptor Antagonist [EPC], Phosphodiesterase 5 Inhibitor [EPC]
Pharm class moa
Endothelin Receptor Antagonists [MoA], Phosphodiesterase 5 Inhibitors [MoA]
UNII
Z9K9Y9WMVL, 742SXX0ICT
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.