List of Products with Paragraph IV Patent Certifications
The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 240-276-8400, before making any decisions based on this information.
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| DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
|---|---|---|---|---|
| Topiramate | Extended-release Capsules | 200 mg | Trokendi XR | 4/3/2014 |
| Tacrolimus | Extended-release Capsules | 0.5 mg, 1 mg, and 5 mg | Astagraf XL | 11/15/2013 |
| Nicotine | Transdermal System | 7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs | Nicoderm CQ | 5/30/2014 |
| Hydrocodone Bitartrate | Extended-release Capsules | 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg | Zohydro ER | 2/26/2014 |
| Glatiramer Acetate | Injection | 40 mg/mL, 1 mL pre-filled syringe | Copaxone | 2/26/2014 |
| Eltrombopag Olamine | Tablets | 50 mg and 75 mg | Promacta | 1/7/2014 |
| Calcium Acetate | Oral Solution | 667 mg/5 mL | Phoslyra | 12/5/2013 |
| Buprenorphine | Transdermal System | 5 mcg/hr, 10 mcg/hr, and 20 mcg/hr | Butrans | 6/6/2013 |
| Asenapine Maleate | Sublingual Tablets | 5 mg and 10 mg | Saphris | 8/13/2013 |
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