Details for New Drug Application (NDA): 021980
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NDA 021980 describes FLUORESCITE, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the FLUORESCITE profile page.
The generic ingredient in FLUORESCITE is fluorescein sodium. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.
The generic ingredient in FLUORESCITE is fluorescein sodium. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.
Summary for 021980
| Tradename: | FLUORESCITE |
| Applicant: | Alcon Labs Inc |
| Ingredient: | fluorescein sodium |
| Patents: | 0 |
Pharmacology for NDA: 021980
| Mechanism of Action | Dyes |
Medical Subject Heading (MeSH) Categories for 021980
Suppliers and Packaging for NDA: 021980
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUORESCITE | fluorescein sodium | INJECTABLE;INTRAVENOUS | 021980 | NDA | Alcon, Inc. | 0065-0092 | 0065-0092-65 | 12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | ||||
| Approval Date: | Mar 28, 2006 | TE: | AP | RLD: | Yes | ||||
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