Methyl - Generic Drug Details
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Generic filers with tentative approvals for METHYL
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 12MG/0.6ML | SOLUTION;SUBCUTANEOUS |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 30MG | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for methyl
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neos Theraps Inc | COTEMPLA XR-ODT | methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489-002 | Jun 19, 2017 | AB | RX | Yes | No | 9,072,680 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Osmotica Pharm Us | RELEXXII | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 216117-002 | Jun 23, 2022 | RX | Yes | No | 9,827,234 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bionpharma | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET;ORAL | 209753-002 | Mar 2, 2018 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
