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FDA Approval Activities for this Drug…
AN-DTPA Kit (for the Preparation of Technetium Tc99m Pentetate Injection Diagnostic for Intravenous Use), CIS-US, NDA 17-714/S21 MAA Kit (Technetium Tc99m Albumin Aggregated Injection), DRAXIMAGE NDA 17-881/SCM-004 7/23/02 7/24/02 MDP Kit (Technetium Tc99m Medronate) Injection, Draximage NDA 18-035/S17 Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin) Injection, Amersham Health NDA 20-372/S13 2/28/03 3/10/03 3/11/03 7/8/03 Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection), Amersham Health NDA 20-372/S3 11/3/01 3/12/02 3/12/02 3/12/02 Myoview 24 (Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection), Amersham Health NDA 20-372/S9 NeoTect (Kit for the Preparation of Technetium Tc 99m Depreotide) Diatide NDA 21-012 Ultra-TechneKow DTE (Technetium Tc99m Generator), Tyco/Healthcare-Mallinckrodt NDA 17-243/SCS-022 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT Injection N/A MACROTEC BRACCO | 017776 BS TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT Injection N/A PULMOLITE CIS | 017881 BS TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT Injection N/A TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT DRAXIMAGE | 017842 BS TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT Injection N/A TECHNESCAN MAA Mallinckrodt | 020887 TECHNETIUM TC-99M APCITIDE Injection N/A ACUTECT DIATIDE RES 020256 TECHNETIUM TC-99M BICISATE KIT Injection N/A/VIAL NEUROLITE BRISTOL MYERS SQUIBB | 021012 TECHNETIUM TC-99M DEPREOTIDE Injection N/A NEO TECT KIT DIATIDE RES 018467 TECHNETIUM TC-99M DISOFENIN KIT Injection N/A HEPATOLITE CIS | 019829 TECHNETIUM TC-99M EXAMETAZIME KIT Injection N/A CERETEC AMERSHAM HLTH | 018272 TECHNETIUM TC-99M GLUCEPTATE KIT Injection N/A TECHNESCAN GLUCEPTATE DRAXIMAGE | 018963 TECHNETIUM TC-99M MEBROFENIN KIT Injection N/A CHOLETEC BRACCO | 018141 TECHNETIUM TC-99M MEDRONATE KIT Injection N/A TECHNETIUM TC 99M MPI MDP AMERSHAM HLTH | 018107 TECHNETIUM TC-99M MEDRONATE KIT Injection N/A MDP-BRACCO BRACCO | 018124 TECHNETIUM TC-99M MEDRONATE KIT Injection N/A CIS-MDP CIS | 017972 TECHNETIUM TC-99M MEDRONATE KIT Injection N/A OSTEOLITE CIS | 018035 TECHNETIUM TC-99M MEDRONATE KIT Injection N/A TECHNESCAN MDP KIT DRAXIMAGE | 019882 TECHNETIUM TC-99M MERTIATIDE KIT Injection N/A TECHNESCAN MAG3 Mallinckrodt | 018321 TECHNETIUM TC-99M OXIDRONATE KIT Injection N/A TECHNESCAN HDP Mallinckrodt | 017264 TECHNETIUM TC-99M PENTETATE KIT Injection N/A TECHNETIUM TC-99M PENTETATE KIT AMERSHAM HLTH | 017714 TECHNETIUM TC-99M PENTETATE KIT Injection N/A AN-DTPA CIS | 018511 TECHNETIUM TC-99M PENTETATE KIT Injection N/A DTPA DRAXIMAGE | 017680 TECHNETIUM TC-99M PYROPHOSPHATE KIT Injection N/A PHOSPHOTEC BRACCO | 019039 TECHNETIUM TC-99M PYROPHOSPHATE KIT Injection N/A CIS-PYRO CIS | 017538 TECHNETIUM TC-99M PYROPHOSPHATE KIT Injection N/A TECHNESCAN PYP KIT Mallinckrodt | 019981 TECHNETIUM TC-99M RED BLOOD CELL KIT Injection N/A ULTRATAG Mallinckrodt | 019785 TECHNETIUM TC-99M SESTAMIBI KIT Injection N/A CARDIOLITE BRISTOL MYERS SQUIBB | 019785 TECHNETIUM TC-99M SESTAMIBI KIT Injection N/A MIRALUMA BRISTOL MYERS SQUIBB | 017771 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR Solution; Injection, 0.0083-2.7 CI/GENERATOR TECHNELITE BRISTOL MYERS SQUIBB | 017243 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR Solution; Injection, 0.25-3 CI/GENERATOR ULTRA-TECHNEKOW FM Mallinckrodt 017944 TECHNETIUM TC-99M SUCCIMER KIT Injection N/A MPI DMSA KIDNEY REAGENT AMERSHAM HLTH | 017858 TECHNETIUM TC-99M SULFUR COLLOID KIT Solution; Injection, N/A AN-SULFUR COLLOID CIS | 017059 TECHNETIUM TC-99M SULFUR COLLOID KIT Solution; Injection, N/A TECHNECOLL Mallinckrodt | 019928 TECHNETIUM TC-99M TEBOROXIME KIT Injection N/A CARDIOTEC BRACCO | 020372 TECHNETIUM TC-99M TETROFOSMIN KIT Injection N/A/VIAL MYOVIEW AMERSHAM HLTH Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin) Injection, Amersham Health DMSA (Kit for the preparation of Tc99m Succimer for Injection), Amersham Health DRAXIMAGE MDP-25 (Technetium Tc 99m Medronate (MDP)), DRAXIMAGE INC. Technetium (99m Tc) Fanolesomab, NeutroSpec (murine monoclonal antibody to CD15), Palatin Technologies, Inc., Approval | NeoTect (Kit for the Preparatio n of Technetium Tc99m Depreotide Injection), Berlex, Formulation Revision | Ultra-TechneKow DTE (Technetium Tc99m Generator), Mallinckrodt, Control Supplement | AN-MDP (Kit for the Preparation of Technetium Tc99m Medronate) Injection, CIS-US, Inc., Control Supplement | Ceretec (Technetium Tc99m Exametazine), GE Healthcare, Labeling Revision | Myoview (Prep Kit for Technetium Tc99m Tetrofosmin) Injection, GE Healthcare, Formulation Revision | Ultra-TechneKow DTE (Technetium Tc 99m Generator), Mallinckrodt Inc., Labeling Revision | Chemet (succimer) Capsules, Ovation Pharma, Labeling Revision | MDP Multidose Utilipak (Technetium Tc99m Medronate) Injection, GE HealthCare, Labeling Revision | Technetium TC-99M Mebrofenin Injection, CIS Inc., Approval | Cardiolite (Technetium Tc99m Sestamibi Kit) Injection, Bristol Myers Squibb, Patient Population Altered | Technetium Tc 99m Sestamibi (technettium tc-99m sestamibi kit) Injection, Mallinckrodt Inc., Approval| MDP-Bracco (technetium tc 99m medronate kit ) Injection, Bracco Diagnostics, Inc., Manufacturing Change or Addition | MDP-Bracco (technetium tc 99m medronate kit) Injection, Bracco Diagnostics, Inc., Manufacturing Change or Addition | Myoview (technetium tc-99m and tetrofosmin kit) Injection, GE Healthcare, Formulation Revision | Technetium Tc 99m Sestamibi Injection, Cardinal Health 414, LLC, Approval | Technetium Tc 99m Albumin Aggregated Kit Injection, Draximage, Control Supplement | Draximage MDP-25 (technetium Tc-99m medronate kit) Injection, Draximage, Formulation Revision | Technetium Tc 99m Sestamibi (technetium tc-99m sestamibi kit) Injection, Pharmalucence, Inc., Approval
  
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