New Paragraph IV Certifications as of March 13, 2018
| DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
|---|---|---|---|---|
| Dapagliflozin | Tablets | 5 mg and 10 mg | Farxiga, 202293 | 1/8/2018 |
| Metformin Hydrochloride | Oral Solution | 500 mg/5 mL | Riomet, 21591 | 2/2/2018 |
| Dapaglifozin and Metformin Hydrochloride | Extended-release Tablets | 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg & 10 mg/1000 mg | Xigduo XR, 205649 | 1/8/2018 |
| Amantadine | Extended-release Capsules | 137 mg | Gocovri, 208944 | 1/16/2018 |
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