Details for New Drug Application (NDA): 208582
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NDA 208582 describes ALTAFLUOR BENOX, which is a drug marketed by Altaire Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ALTAFLUOR BENOX profile page.
The generic ingredient in ALTAFLUOR BENOX is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
The generic ingredient in ALTAFLUOR BENOX is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.
Summary for 208582
| Tradename: | ALTAFLUOR BENOX |
| Applicant: | Altaire Pharms Inc |
| Ingredient: | benoxinate hydrochloride; fluorescein sodium |
| Patents: | 0 |
Pharmacology for NDA: 208582
| Mechanism of Action | Dyes |
Suppliers and Packaging for NDA: 208582
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALTAFLUOR BENOX | benoxinate hydrochloride; fluorescein sodium | SOLUTION/DROPS;OPHTHALMIC | 208582 | NDA | Altaire Pharmaceuticals Inc. | 59390-218 | 59390-218-05 | 5 mL in 1 BOTTLE, DROPPER (59390-218-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.4%;0.25% | ||||
| Approval Date: | Dec 14, 2017 | TE: | RLD: | Yes | |||||
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