Diagnostic Dye Drug Class List
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Drugs in Drug Class: Diagnostic Dye
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Long Grove Pharms | AK-FLUOR 10% | fluorescein sodium | INJECTABLE;INTRAVENOUS | 022186-001 | Aug 8, 2008 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Long Grove Pharms | AK-FLUOR 25% | fluorescein sodium | INJECTABLE;INTRAVENOUS | 022186-002 | Aug 8, 2008 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Altaire Pharms Inc | ALTAFLUOR BENOX | benoxinate hydrochloride; fluorescein sodium | SOLUTION/DROPS;OPHTHALMIC | 208582-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Provepharm Sas | BLUDIGO | indigotindisulfonate sodium | SOLUTION;INTRAVENOUS | 216264-001 | Jul 8, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Provepharm Sas | BLUDIGO | indigotindisulfonate sodium | SOLUTION;INTRAVENOUS | 216264-001 | Jul 8, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Provepharm Sas | BLUDIGO | indigotindisulfonate sodium | SOLUTION;INTRAVENOUS | 216264-001 | Jul 8, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Provepharm Sas | BLUDIGO | indigotindisulfonate sodium | SOLUTION;INTRAVENOUS | 216264-001 | Jul 8, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
