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File Name Date Produced File Size Link FDA CBER 2021 5683 1051266 1053273_125742_S1_M5_C4591001 S D lb.zip (xpt) September 1, 2023 2 MB FDA CBER 2021 5683 1053274 1058198_125742_S1_M5_C4591001 S D mh.zip (xpt) September 1, 2023 11 MB FDA CBER 2021 5683 1058199 1058203_125742_S1_M5_C4591001 S D suppie.zip (xpt) September 1, 2023 7 KB FDA CBER 2021 5683 1066333 1067534_125742_S6_M5_c4591001 A D adsl.zip (xpt) September 1, 2023 7 MB FDA CBER 2021 5683 1067535 1067562_125742_S6_M5_c4591001 A D adxb.zip (xpt) September 1, 2023 47 KB FDA CBER 2021 5683 1067563 1070765_125742_S6_M5_c4591001 S D ex.zip (xpt) September 1, 2023 2 MB FDA CBER 2021 5683 1070766 1071967_125742_S6_M5_c45941001 S D dm.zip (xpt) September 1, 2023 1 MB FDA CBER 2021 5683 1071968 1071995_125742_S6_M5_c45941001 S D xb.zip (xpt) September 1, 2023 25 KB FDA CBER 2021 5683 1040914_125742_S1_M5_bnt162 01 S D mh.zip (xpt) September 1, 2023 6 KB FDA CBER 2021 5683 1040915 1045839_125742_S1_M5_C4591001 A D admh.zip (xpt) September 1, 2023 23 MB FDA CBER 2021 5683 1045840 1049564_125742_S1_M5_C4591001 S D co.zip (xpt) September 1, 2023 1 MB FDA CBER 2021 5683 1049565 1049659_125742_S1_M5_C4591001 S D faho.zip (xpt) September 1, 2023 80 KB FDA CBER 2021 5683 1049660 1051265_125742_S1_M5_C4591001 S D ho.zip (xpt) September 1, 2023 734 KB FDA CBER 2021 5683 1072081 1072125_125742_S6_M5_define2 0 0.xsl September 1, 2023 183 KB FDA CBER 2021 5683 1072062 1072080_125742_S6_M5_define 1.xml September 1, 2023 74 KB FDA CBER 2021 5683 1071996 1072061_125742_S6_M5_define.xml September 1, 2023 283 KB FDA CBER 2021 5683 1072126 1072170_125742_S6_M5_define2 0 0 2.xsl September 1, 2023 183 KB FDA CBER 2021 5683 1060089_28H_IND27034 c4591001 safety fa eff AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx September 1, 2023 14 KB FDA CBER 2021 5683 1060088_28G_IND27034 BNT162 01 Multiple baseline records in VS.xlsx September 1, 2023 16 KB FDA CBER 2021 5683 1060086 1060087_28F_IND27034 BNT162 01 Multiple baseline records in LB.xlsx September 1, 2023 26 KB FDA CBER 2021 5683 1060085_28E_IND27034 BNT162 01 AEACN is DRUG WITHDRAWN but no ADVERSE EVENT record in DS.xlsx September 1, 2023 11 KB FDA CBER 2021 5683 1060004 1060071_28B_3 bnt162 01.xlsx September 1, 2023 133 KB FDA CBER 2021 5683 1058209 1060003_28A_2 c4591001 safety fa eff.xlsx September 1, 2023 3 MB FDA CBER 2021 5683 1064475 1066330_28K_Part III CoreDF IND27034 c4591001 subset 2021 04 19T10 50.xlsx September 1, 2023 3 MB FDA CBER 2021 5683 1064474_28J_Part II IND27034 12 15years AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record (1).xlsx September 1, 2023 16 KB FDA CBER 2021 5683 1060090 1064473_28I_Part II CoreDF IND27034 12 15years.xlsx September 1, 2023 7 MB 9_2_BLA 125742 0_06 25 2021_Telecon_Information Reques.pdf September 1, 2023 812 KB 98_BLA 125742 0_08 19 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 784 KB 97_1_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf September 1, 2023 785 KB 96_2_BLA 125742 0_08 19 2021_Telecon_Information Reques.pdf September 1, 2023 756 KB 91_2_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 754 KB 90_1_BLA 125742 0_08 18 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 810 KB 88_2_BLA 125742 0_08 18 2021_Telecon_Information Reques.pdf September 1, 2023 746 KB 82_BLA 125742 0_08 17 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 731 KB 80_2_BLA 125742 0_08 17 2021_Telecon_Information Reques.pdf September 1, 2023 782 KB 76_BLA 125742 0_08 16 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 793 KB 72_BLA 125742 0_08 13 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 753 KB 71_6_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf September 1, 2023 790 KB 70_2_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf September 1, 2023 792 KB 6_BLA 125742 0_06 09 2021_Telecon_Information Reques.pdf September 1, 2023 732 KB 69_1_BLA 125742 0_08 13 2021_Telecon_Information Reques.pdf September 1, 2023 802 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125742 0_07 29 2021_Telecon_Information Reques.pdf September 1, 2023 804 KB 36_BLA 125742 0_07 28 2021_Telecon_Labeling Target Cl.pdf September 1, 2023 746 KB 35_BLA 125742 0_07 28 2021_Telecon_Information Reques.pdf September 1, 2023 776 KB 34_2_BLA 125742 0_07 27 2021_Telecon_Information Reques.pdf September 1, 2023 742 KB 31_2_BLA 125742 0_07 26 2021_Telecon_Information Reques.pdf September 1, 2023 810 KB 30_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf September 1, 2023 787 KB 29_BLA 125742 0_07 20 2021_Telecon_Information Reques.pdf September 1, 2023 748 KB 30A_BLA 125742 0_07 22 2021_Telecon_Information Reques.pdf September 1, 2023 946 KB 28C_BLA 125742 0_07 20 2021_Memo_Review.pdf September 1, 2023 783 KB 28_BLA 125742 0_07 20 2021_Memo_Review.pdf September 1, 2023 697 KB 24_2_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf September 1, 2023 733 KB 23_1_BLA 125742 0_07 15 2021_Telecon_Information Reques.pdf September 1, 2023 739 KB 22_BLA 125742 0_07 15 2021_Meeting Summary_Committee.pdf September 1, 2023 1 MB 20_1_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf September 1, 2023 734 KB 19_2_BLA 125742 0_07 13 2021_Telecon_Information Reques.pdf September 1, 2023 748 KB 17_BLA 125742 0_07 06 2021_Telecon_Advice_PNR Accepta.pdf September 1, 2023 728 KB 125742_S79_M1_cover.pdf September 1, 2023 2 MB 125742_S6_M5_csdrg.pdf September 1, 2023 814 KB 125742_S6_M5_adrg.pdf September 1, 2023 776 KB 16_BLA 125742 0_07 06 2021_Telecon_Information Reques.pdf September 1, 2023 735 KB 14_BLA 125742 0_07 02 2021_Telecon_Advice.pdf September 1, 2023 770 KB 12_BLA 125742 0_07 01 2021_Memo_Filing Checklist_RPM.pdf September 1, 2023 1 MB 125742_S54_M1_vial rl 7302 rocky mount hospira.pdf September 1, 2023 695 KB 125742_S54_M1_diluent vial fresenius kabi.pdf September 1, 2023 717 KB 125742_S54_M1_diluent carton fresenius kabi.pdf September 1, 2023 730 KB 125742_S54_M1_carton ca 7114 rocky mount hospira.pdf September 1, 2023 679 KB 125742_S6_M5_acrf.pdf September 1, 2023 3 MB 125742_S38_M1_response 22jul2021.pdf September 1, 2023 2 MB 125742_S38_M1_cover.pdf September 1, 2023 2 MB 28L_BLA 125742 0_07 20 2021_Memo_Review.pdf September 1, 2023 744 KB 28D_BLA 125742 0_07 20 2021_Memo_Review.pdf September 1, 2023 864 KB 125742_S1_M5_CRF_c4591001 1095 10951101.pdf September 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1095 10951080.pdf September 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1095 10951009.pdf September 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1093 10931141.pdf September 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1093 10931128.pdf September 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1093 10931067.pdf September 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1093 10931058.pdf September 1, 2023 1 MB 125742_S1_M5_5351_c4591001 interim mth6 narrative sensitive.pdf September 1, 2023 22 MB 125742_S1_M5_5351_c4591001 interim mth6 compliance.pdf September 1, 2023 94 MB 114_2_BLA 125742 0_08 21 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 784 KB 113_2_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf September 1, 2023 874 KB 112A_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf September 1, 2023 766 KB 112_1_BLA 125742 0_08 21 2021_Telecon_Information Reques.pdf September 1, 2023 747 KB 11_BLA 125742 0_06 29 2021_Telecon_Information Reques.pdf September 1, 2023 701 KB 106_2_BLA 125742 0_08 20 2021_Telecon_Labeling via FAX_e.pdf September 1, 2023 822 KB 104B_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf September 1, 2023 675 KB 104A_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf September 1, 2023 675 KB 104_BLA 125742 0_08 20 2021_Telecon_Information Reques.pdf September 1, 2023 747 KB 125742_S1_M5_CRF_c4591001 1095 10951256.pdf September 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1095 10951228.pdf September 1, 2023 3 MB 125742_S1_M5_CRF_c4591001 1095 10951206.pdf September 1, 2023 2 MB 125742_S1_M5_CRF_c4591001 1095 10951204.pdf September 1, 2023 1 MB 125742_S1_M5_CRF_c4591001 1095 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