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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 Pharms Ltd 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. Two suppliers are listed for this compound. Additional details are available on the fluorescein sodium profile page.

Summary for NDA: 021980

Alcon Pharms Ltd
fluorescein sodium
Formulation / Manufacturing:see details

Pharmacology for NDA: 021980

Mechanism of ActionDyes

Suppliers and Packaging for NDA: 021980

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluorescein sodium
INJECTABLE;INTRAVENOUS 021980 NDA Alcon, Inc. 0065-0092 0065-0092-05 12 VIAL in 1 CARTON (0065-0092-05) > 5 mL in 1 VIAL
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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.