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Specgx LLC FDA Approvals
10 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| TOFACITINIB CITRATENew drugJun 3, 2026TABLET, ORAL |
| BUPRENORPHINE HYDROCHLORIDENew drugDec 10, 2025TABLET, SUBLINGUAL |
| PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugDec 17, 2024TABLET, CHEWABLE, ORAL |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATENew drugAug 31, 2023CAPSULE, EXTENDED RELEASE, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| MORPHINE SULFATENew drugAug 21, 2023TABLET, ORAL |
| POSACONAZOLENew drugMay 10, 2022TABLET, DELAYED RELEASE, ORAL |
| VIGABATRINNew drugJul 28, 2021FOR SOLUTION, ORAL |
| AMPHETAMINE SULFATENew drugJan 22, 2021TABLET, ORAL |