The Paragraph Four Report®
Paragraph IV Activity for February 2021
New Certifications as reported by FDA on February 8 and 23, 2021
1. Katerzia®(amlodipine) Oral Suspension 1 mg/mL on 12/29/2020
2. Balcoltra®(levonorgestrel and ethinyl estradiol) 0.1 mg/0.02 mg 7/14/2020
3. Osphena®(ospemifene) Tablets 60 mg on 12/29/2020
4. Car…Read more
The Paragraph Four Report®
Paragraph IV Activity for January 2021
New Certifications as reported by FDA on January 26, 2021
1. Tirosint®(levothyroxine) Capsules 112 mcg on 12/18/2020
2. Ibrance®(palbociclib) Tablets 75 mg, 100mg, and 125mg on 11/24/2020
3. Xeljanz XR®(tofacitinib) Extended-release Tablets 22 mg on 12/28/2020
4. Ore…Read more
Makena®(hydroxyprogesterone) Injection
Annual Sales
Company COVIS PHARMA (AMAG)
Date of First Filing September 28, 2020
Paragraph IV Applicant: Aurobindo
Case Name: COVIS PHARMA GMBH et al v. EUGIA PHARMA SPECIALTIES LTD et al
Court/Case #: Delaware District Court (dedc) 1:2021cv00003
Date Filed: 1/4/21
Judge: Connelly
Product…Read more
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