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FDA Approval Activities for this Drug… OptiMark (gadoversetamide) Injection, Tyco/Mallinckrodt Health Care NDA 20-937/S3 NDA 20-975/S3 NDA 20-976/S3 1/31/03 2/12/03 2/13/03 OptiMark (gadoversetamide) Injection Mallinckrodt, NDA 20-937 | NDA 20-975 | NDA 20-976 | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Control Supplement | OptiMARK (gadoversetamide) Injection, Tyco Healthcare, Efficacy Supp. w/Clin. Data | OptiMARK (gadoversetamide) Injection, Mallinckrodt Inc., Labeling Revision | OptiMARK (gadoversetamide) Injection, Mallinckrodt, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com