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Details for New Drug Application (NDA): 202207

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NDA 202207 describes LYMPHOSEEK KIT, which is a drug marketed by Navidea Biopharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LYMPHOSEEK KIT profile page.

The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.

Summary for NDA: 202207

Tradename:
LYMPHOSEEK KIT
Applicant:
Navidea Biopharms
Ingredient:
technetium tc-99m tilmanocept
Patents:2

Suppliers and Packaging for NDA: 202207

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYMPHOSEEK KIT
technetium tc-99m tilmanocept
INJECTABLE;INJECTION 202207 NDA Navidea Biopharmaceuticals, Inc. 52579-1600 52579-1600-5 1 KIT in 1 CARTON (52579-1600-5) > 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (52579-1695-1) * 1 INJECTION, SOLUTION in 1 VIAL (52579-1649-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Mar 13, 2013TE:RLD:Yes
Patent:6,409,990Patent Expiration:May 12, 2020Product Flag?Substance Flag?YDelist Request?
Patent:9,439,985Patent Expiration:Sep 27, 2033Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Jun 13, 2017
Regulatory Exclusivity Use:GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY


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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.

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