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Astepro Allergy®(azelastine) Nasal Spray
Annual Sales
Company BAYER
Date of First Filing July 12, 2021

Special Notes: This is an OTC product. FDA reported that both the Astepro Allergy and Children’s Astepro Allergy received their respective filings on July 12, 2021. These products share the same NDA number. The case below does not…Read more

Profile picture of parryashford 3 days, 13 hours ago

The Paragraph Four Report®
Paragraph IV Activity for September 2021

New Certifications as reported by FDA on September 7 and 21, 2021

1. Tivicay PD®(dolutegravir) Tablets for Suspension 5 mg on 7/21/2021
2. Nayzilam®(midazolam) Nasal Spray 5 mg/spray on 6/1/2021
3. Invega Trinza®(paliperidone) Extended-release Injectable Suspension 273…Read more

Profile picture of parryashford 2 weeks, 1 day ago

Eucrisa®(crisaborole) Topical Ointment
Annual Sales
Company ANACOR
Date of First Filing June 14, 2021

Paragraph IV Applicant: Alkem
Case Name: ANACOR PHARMACEUTICALS INC et al v. ALKEM LABORATORIES LTD
Court/Case #: Delaware District Court (dedc) 1:2021cv01348
Date Filed: 9/24/21
Judge:
Product Strength: 2%
Litigated Patents…Read more

Profile picture of parryashford 2 weeks, 4 days ago
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