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Details for New Drug Application (NDA): 020314

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NDA 020314 describes OCTREOSCAN, which is a drug marketed by Mallinkrodt Nuclear 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 OCTREOSCAN profile page.

The generic ingredient in OCTREOSCAN is indium in-111 pentetreotide kit. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 pentetreotide kit profile page.

Summary for NDA: 020314

Tradename:
OCTREOSCAN
Applicant:
Mallinkrodt Nuclear
Ingredient:
indium in-111 pentetreotide kit
Patents:2

Suppliers and Packaging for NDA: 020314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OCTREOSCAN
indium in-111 pentetreotide kit
INJECTABLE;INJECTION 020314 NDA Mallinckrodt Inc. 0019-9050 0019-9050-40 1 KIT in 1 BOX (0019-9050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS
OCTREOSCAN
indium in-111 pentetreotide kit
INJECTABLE;INJECTION 020314 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-050 69945-050-40 1 KIT in 1 BOX (69945-050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3mCi/ML
Approval Date:Jun 2, 1994TE:RLD:Yes
Patent:5,776,894Patent Expiration:Jul 7, 2015Product Flag?YSubstance Flag?YDelist Request?
Patent:6,123,916Patent Expiration:Sep 26, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR THE DETECTION OF NEUROENDOCRINE TUMORS

Expired Orange Book Patents for NDA: 020314

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinkrodt Nuclear
OCTREOSCAN
indium in-111 pentetreotide kit
INJECTABLE;INJECTION020314-001Jun 2, 19945,384,113► subscribe
Mallinkrodt Nuclear
OCTREOSCAN
indium in-111 pentetreotide kit
INJECTABLE;INJECTION020314-001Jun 2, 19945,776,894► subscribe
Mallinkrodt Nuclear
OCTREOSCAN
indium in-111 pentetreotide kit
INJECTABLE;INJECTION020314-001Jun 2, 19945,753,627► subscribe
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