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... 21 CFR 314.150 (c )). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150 (c) is without prejudice to refiling. Table 1.-Application No. Drug Applicant-NDA 6-008 Mesantoin (mephenytoin) Tablets Novartis Pharmaceuticals Corp, One Health Plaza, East Hanover, NJ 07936-1080-NDA 9-000 Cafergot (ergotamine tartrate and Do. caffeine) Suppository, 1 milligram (mg )/ 100 mg and 2 mg / 100 mg-NDA 9-561 Hypaque (diatrizoate sodium) GE Healthcare, Inc, 101 Carnegie Center, Princeton, NJ 08540-NDA 9-658 Hydrocortisone Tablets Smith, Miller and Patch, Inc, Division of Cooper Vision, Inc, c / o Cooper Laboratories, Inc, 455 E. Middlefied Rd, Mountain View, CA 94043-NDA 9-942 Deltra (prednisone) Tablets Merck & Co, Inc, P.O. Box 4, BLA-20, West Point, PA 19486-0004-NDA 10-051 Hydeltra (prednisolone) Tablets Do.-NDA ...
URL: http://edocket.access.gpo.gov/2010/2010-17785.htm

 

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