Details for New Drug Application (NDA): 202788
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NDA 202788 describes SUBSYS, which is a drug marketed by Btcp Pharma and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SUBSYS profile page.
The generic ingredient in SUBSYS is fentanyl. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
The generic ingredient in SUBSYS is fentanyl. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 202788
| Tradename: | SUBSYS |
| Applicant: | Btcp Pharma |
| Ingredient: | fentanyl |
| Patents: | 10 |
Medical Subject Heading (MeSH) Categories for 202788
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY;SUBLINGUAL | Strength | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 4, 2012 | TE: | RLD: | Yes | |||||
| Patent: | 10,016,403 | Patent Expiration: | Jan 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,610,523 | Patent Expiration: | Jan 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,486,972 | Patent Expiration: | Apr 27, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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