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Last Updated: January 27, 2021

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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. Three suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.
Summary for 021980
Applicant:Alcon Labs Inc
Ingredient:fluorescein sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 021980
Mechanism of ActionDyes
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:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date:Mar 28, 2006TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

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