Details for New Drug Application (NDA): 204803
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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: | ⤷ Sign Up | Patent Expiration: | Jan 12, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 12, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TO PRODUCE POST-SURGICAL ANALGESIA | ||||||||
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