Details for New Drug Application (NDA): 204410
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NDA 204410 describes OPSUMIT, which is a drug marketed by Actelion and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OPSUMIT profile page.
The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.
The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the macitentan profile page.
Summary for 204410
| Tradename: | OPSUMIT |
| Applicant: | Actelion |
| Ingredient: | macitentan |
| Patents: | 5 |
Pharmacology for NDA: 204410
| Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 204410
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPSUMIT | macitentan | TABLET;ORAL | 204410 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-501 | 66215-501-15 | 1 BLISTER PACK in 1 CARTON (66215-501-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK |
| OPSUMIT | macitentan | TABLET;ORAL | 204410 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-501 | 66215-501-30 | 1 BOTTLE in 1 CARTON (66215-501-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 18, 2013 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Feb 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING | ||||||||
| Regulatory Exclusivity Expiration: | Aug 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 11, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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