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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY | ||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES | |||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES | |||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | TOPICAL TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES | |||
Bausch | JUBLIA | efinaconazole | SOLUTION;TOPICAL | 203567-001 | Jun 6, 2014 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | |||
Horizon Pharma Usa | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-003 | Jul 26, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY,GASTROINTESTINAL,DERMATOLOGIC DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |