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Generated: November 14, 2018

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Details for New Drug Application (NDA): 019829

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NDA 019829 describes CERETEC, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from three suppliers. Additional details are available on the CERETEC profile page.

The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
Summary for 019829
Tradename:CERETEC
Applicant:Ge Healthcare
Ingredient:technetium tc-99m exametazime kit
Patents:0
Pharmacology for NDA: 019829
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 019829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CERETEC technetium tc-99m exametazime kit INJECTABLE;INJECTION 019829 NDA Medi-Physics Inc. dba GE Healthcare. 17156-022 17156-022-05 5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL
CERETEC technetium tc-99m exametazime kit INJECTABLE;INJECTION 019829 NDA Medi-Physics Inc. 17156-023 17156-023-05 1 KIT in 1 CARTON (17156-023-05) * 5 VIAL in 1 TRAY > 4.5 mL in 1 VIAL * 5 VIAL in 1 TRAY > 1 mL in 1 VIAL * 5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Dec 30, 1988TE:RLD:Yes

Expired US Patents for NDA 019829

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare CERETEC technetium tc-99m exametazime kit INJECTABLE;INJECTION 019829-001 Dec 30, 1988 ➤ Sign Up ➤ Sign Up
Ge Healthcare CERETEC technetium tc-99m exametazime kit INJECTABLE;INJECTION 019829-001 Dec 30, 1988 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Argus Health
McKinsey
Baxter
Daiichi Sankyo
Dow
Queensland Health
US Department of Justice

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