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Generated: November 15, 2018

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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 Cardinal Health 414 and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.
Summary for 202207
Tradename:LYMPHOSEEK KIT
Applicant:Cardinal Health 414
Ingredient:technetium tc-99m tilmanocept
Patents:2
Generic Entry Opportunity Date for 202207
Generic Entry Date for 202207*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)
LYMPHOSEEK KIT technetium tc-99m tilmanocept INJECTABLE;INJECTION 202207 NDA Navidea Biopharmaceuticals, Inc. 52579-1604 52579-1604-5 1 KIT in 1 CARTON (52579-1604-5) > 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (52579-1695-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Mar 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 13, 2021
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
Regulatory Exclusivity Expiration:Mar 13, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:May 12, 2020Product Flag?Substance Flag?YDelist Request?

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