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Nymalize®(nimodipine) Oral Solution
Annual Sales
Company ARBOR
Date of First Filing November 29, 2021

Paragraph IV Applicant: Alkem
Case Name: ARBOR PHARMACEUTICALS LLC v. ALKEM LABORATORIES LTD
Court/Case #: New Jersey District Court (njdc) 1:2022cv00143
Date Filed: 1/11/22
Judge: Williams
Product Strength: 6 mg/mL
Litigated…Read more

Profile picture of parryashford 2 days, 17 hours ago

The Paragraph Four Report®
Paragraph IV Activity for December 2021

New Certifications as reported by FDA on December 13 and 28, 2021

1. Calquence®(acalabrutini) Capsules 100 mg on 11/1/2021
2. Nymalize®(nimodipine) Oral Solution 6 mg/mL on 11/29/2021
3. Antizol®(fomepizole) Injection 1.5g/1.5mL on 11/1/2021

Comments: The December lis…Read more

Profile picture of parryashford 2 weeks, 1 day ago

Onureg®(azacitidine) Tablets
Annual Sales $17M (as reported by Bristol Myers)
Company CELGENE
Date of First Filing September 30, 2021

Paragraph IV Applicant: Accord
Case Name: CELGENE CORPORATION et al v. ACCORD HEALTHCARE INC
Court/Case #: Delaware District Court (dedc) 1:2021cv01795
Date Filed: 12/22/21
Judge: Andrews
Prod…Read more

Profile picture of parryashford 3 weeks, 2 days ago
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