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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | A-METHAPRED | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 085853-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ironshore Pharms | JORNAY PM | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 209311-003 | Aug 8, 2018 | RX | Yes | No | 11,241,392 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Bausch | ANDROID 25 | methyltestosterone | TABLET;ORAL | 087147-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abraxis Pharm | METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 089188-001 | Mar 28, 1986 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eugia Pharma | METHYLPREDNISOLONE SODIUM SUCCINATE | methylprednisolone sodium succinate | INJECTABLE;INJECTION | 207667-004 | Dec 15, 2015 | DISCN | 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 |

