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Last Updated: October 31, 2024

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.
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:RXDosage:SOLUTION;INFILTRATIONStrength660MG/5ML (132MG/ML)
Approval Date:Feb 1, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 1, 2024
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 12, 2041Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 12, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TO PRODUCE POST-SURGICAL ANALGESIA

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