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Details for New Drug Application (NDA): 205690

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NDA 205690 describes CHOLINE C-11, which is a drug marketed by Global Isotopes Llc, Mcprf, and Univ Tx Md Anderson, and is included in three NDAs. It is available from three suppliers. Additional details are available on the CHOLINE C-11 profile page.

The generic ingredient in CHOLINE C-11 is choline c-11. There are ninety-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the choline c-11 profile page.

Summary for NDA: 205690

Tradename:
CHOLINE C-11
Applicant:
Univ Tx Md Anderson
Ingredient:
choline c-11
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205690

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 205690

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHOLINE C-11
choline c-11
INJECTABLE;INTRAVENOUS 205690 ANDA The University of Texas MD Anderson Cancer Center 60215-110 60215-110-08 8 mL in 1 VIAL, GLASS (60215-110-08)
CHOLINE C-11
choline c-11
INJECTABLE;INTRAVENOUS 205690 ANDA The University of Texas MD Anderson Cancer Center 60215-111 60215-111-10 10 mL in 1 VIAL, GLASS (60215-111-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength4-33.1mCi/ML
Approval Date:Oct 29, 2015TE:APRLD:No


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