New Paragraph IV Certifications as of July 31, 2018
DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
---|---|---|---|---|
Abiraterone Acetate | Tablets | 125 mg | Yonsa; 210308 | 7/23/2018 |
Bendamustine Hydrochloride | Injection | 100 mg/4 mL (25 mg/mL) multiple-dose vials | Bendamustine Hydrochlride Injection; 205580 | 7/17/2018 |
Efinaconazole | Topical Solution | 10% | Jublia; 203567 | 6/6/2018 |
Fingolimod | Capsules | 0.25 mg | Gilenya; 22527 | 7/18/2018 |
Teriflunomide | Tablets | 7 mg and 14 mg | Aubagio; 202992 | 9/12/2016 |
No comments