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125294orig1s000 - food and drug administration · attention: deborah a. jaskot, m.s., r.a.c....

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125294Orig1s000 OTHER ACTION LETTERS

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Page 1: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125294Orig1s000

OTHER ACTION LETTERS

Page 2: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 3: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 4: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 5: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 6: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 7: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 8: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454
Page 9: 125294Orig1s000 - Food and Drug Administration · Attention: Deborah A. Jaskot, M.S., R.A.C. Vice-President, Regulatory Affairs 1090 Horsham Road P.O. Box 1090 North Wales, PA 19454

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