Details for New Drug Application (NDA): 204803
✉ Email this page to a colleague
NDA 204803 describes POSIMIR, which is a drug marketed by Innocoll and is included in one NDA. There are six patents protecting this drug. Additional details are available on the POSIMIR profile page.
The generic ingredient in POSIMIR is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
The generic ingredient in POSIMIR is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
Summary for 204803
| Tradename: | POSIMIR |
| Applicant: | Innocoll |
| Ingredient: | bupivacaine |
| Patents: | 6 |
Medical Subject Heading (MeSH) Categories for 204803
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INFILTRATION | Strength | 660MG/5ML (132MG/ML) | ||||
| Approval Date: | Feb 1, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 1, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,400,019 | Patent Expiration: | Jan 12, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,771,624 | Patent Expiration: | Jan 12, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO PRODUCE POST-SURGICAL ANALGESIA | ||||||||
Complete Access Available with Subscription
