Sequences
Sequences represent individual submission packages within an application. Each sequence is a numbered eCTD lifecycle event that progresses through publishing, QC, dispatch, and authority acknowledgement. The sequence log is the definitive submission history.
| Seq # | Application | Type | Status | Publishing Jobs | Submitted | Acknowledged | Created |
|---|---|---|---|---|---|---|---|
| 0001 | FDA-2024-0001 | Annual Report | Pending | 3 | — | 2023-09-17 | 2023-04-08 |
| 0002 | EMA-2023-0002 | Type IB Variation | Pending | 3 | — | 2024-02-01 | 2022-11-16 |
| 0003 | PMDA-2022-0003 | Type IB Variation | Submitted | 0 | — | — | 2022-02-28 |
| 0004 | NMPA-2021-0004 | Renewal | Approved | 2 | — | — | 2022-07-29 |
| 0005 | ANVISA-2020-0005 | Type IB Variation | Overdue | 3 | — | 2024-03-01 | 2022-12-22 |
| 0006 | HC-2024-0006 | Type IA Variation | Blocked | 0 | 2023-10-03 | 2024-03-05 | 2023-04-10 |
| 0007 | TGA-2023-0007 | Type II Variation | Failed | 3 | 2024-05-06 | — | 2022-08-01 |
| 0008 | MHRA-2022-0008 | Initial Marketing Authorisation | In Progress | 2 | 2022-10-30 | — | 2022-01-24 |
| 0009 | SwissMedic-2021-0009 | Annual Report | Active | 0 | 2023-10-06 | 2023-06-23 | 2023-03-18 |
| 0010 | MFDS-2020-0010 | Response to Questions | Blocked | 0 | 2023-04-24 | — | 2022-06-12 |
| 0011 | TFDA-2024-0011 | Labeling Update | Approved | 3 | 2022-06-22 | 2024-05-06 | 2022-10-25 |
| 0012 | HSA-2023-0012 | Labeling Update | Pending | 3 | — | — | 2023-01-13 |
| 0013 | CDSCO-2022-0013 | Type II Variation | Blocked | 1 | 2022-09-22 | 2023-07-20 | 2022-11-22 |
| 0014 | COFEPRIS-2021-0014 | Response to Questions | Overdue | 3 | — | 2024-06-21 | 2022-11-19 |
| 0015 | ANMAT-2020-0015 | Initial Marketing Authorisation | Completed | 0 | 2024-06-08 | — | 2022-06-28 |
| 0016 | TITCK-2024-0016 | Response to Questions | Failed | 1 | 2023-01-02 | 2024-06-12 | 2022-11-20 |
| 0017 | SFDA-2023-0017 | Response to Questions | Approved | 3 | 2024-06-09 | 2023-12-21 | 2022-11-26 |
| 0018 | SAHPRA-2022-0018 | Urgent Safety Restriction | Active | 3 | — | 2023-11-07 | 2023-04-13 |
| 0019 | Roszdravnadzor-2021-0019 | Urgent Safety Restriction | In Progress | 3 | — | — | 2022-12-19 |
| 0020 | MOH-IL-2020-0020 | Response to Questions | Active | 1 | 2022-06-18 | 2023-09-26 | 2022-05-13 |
| 0021 | FDA-2024-0021 | Type II Variation | Completed | 2 | 2024-03-23 | 2023-07-28 | 2022-01-13 |
| 0022 | EMA-2023-0022 | Annual Report | Active | 2 | 2022-09-01 | 2023-12-12 | 2023-02-01 |
| 0023 | PMDA-2022-0023 | Renewal | Submitted | 0 | 2023-07-15 | 2024-05-21 | 2023-04-10 |
| 0024 | NMPA-2021-0024 | Annual Report | In Progress | 1 | 2023-07-12 | 2024-05-20 | 2023-04-13 |
| 0025 | ANVISA-2020-0025 | Initial Marketing Authorisation | Draft | 0 | — | — | 2022-12-05 |
| 0026 | HC-2024-0026 | Response to Questions | Blocked | 2 | — | — | 2022-04-09 |
| 0027 | TGA-2023-0027 | Initial Marketing Authorisation | Draft | 1 | 2024-03-10 | — | 2022-06-28 |
| 0028 | MHRA-2022-0028 | Type II Variation | Failed | 3 | 2022-11-21 | — | 2023-04-24 |
| 0029 | SwissMedic-2021-0029 | Type IB Variation | Active | 3 | — | 2023-08-12 | 2022-08-27 |
| 0030 | MFDS-2020-0030 | Safety Update | Active | 1 | 2024-05-23 | 2023-11-01 | 2023-01-29 |
| 0031 | TFDA-2024-0031 | Type IA Variation | Active | 0 | 2024-04-17 | 2024-05-10 | 2022-01-06 |
| 0032 | HSA-2023-0032 | Labeling Update | Pending | 2 | 2024-02-04 | — | 2023-03-09 |
| 0033 | CDSCO-2022-0033 | Type IA Variation | In Progress | 3 | 2022-12-27 | 2023-10-09 | 2022-09-08 |
| 0034 | COFEPRIS-2021-0034 | Renewal | Pending | 0 | 2022-04-23 | — | 2023-05-10 |
| 0035 | ANMAT-2020-0035 | Type II Variation | Submitted | 3 | 2024-03-18 | — | 2022-09-13 |
| 0036 | TITCK-2024-0036 | Type IB Variation | Submitted | 1 | 2023-09-30 | — | 2022-04-07 |
| 0037 | SFDA-2023-0037 | Labeling Update | Failed | 3 | 2023-08-11 | 2024-07-23 | 2022-09-06 |
| 0038 | SAHPRA-2022-0038 | Annual Report | Blocked | 1 | 2023-07-31 | 2024-03-15 | 2022-04-17 |
| 0039 | Roszdravnadzor-2021-0039 | Response to Questions | Failed | 3 | 2022-10-08 | 2024-04-23 | 2022-05-24 |
| 0040 | MOH-IL-2020-0040 | Type IA Variation | Overdue | 0 | 2023-05-21 | — | 2022-01-02 |
| 0041 | FDA-2024-0041 | Urgent Safety Restriction | Failed | 0 | — | 2023-10-27 | 2023-01-03 |
| 0042 | EMA-2023-0042 | Annual Report | Draft | 2 | — | 2024-04-13 | 2023-01-17 |
| 0043 | PMDA-2022-0043 | Type II Variation | Pending | 2 | 2022-08-10 | 2024-02-22 | 2023-02-12 |
| 0044 | NMPA-2021-0044 | Type II Variation | In Progress | 0 | — | 2024-04-04 | 2022-12-05 |
| 0045 | ANVISA-2020-0045 | Renewal | Failed | 1 | 2024-05-31 | 2024-05-31 | 2022-12-15 |
| 0046 | HC-2024-0046 | Type IA Variation | Active | 2 | 2023-09-07 | — | 2022-04-05 |
| 0047 | TGA-2023-0047 | Labeling Update | Approved | 0 | — | — | 2022-08-30 |
| 0048 | MHRA-2022-0048 | Type IA Variation | Submitted | 3 | 2023-01-02 | — | 2023-05-14 |
| 0049 | SwissMedic-2021-0049 | Annual Report | Pending | 1 | 2024-01-30 | 2024-04-09 | 2022-12-07 |
| 0050 | MFDS-2020-0050 | Annual Report | Active | 1 | 2024-02-25 | — | 2023-04-18 |
| 0051 | TFDA-2024-0051 | Response to Questions | Approved | 1 | 2023-06-02 | — | 2022-04-15 |
| 0052 | HSA-2023-0052 | Labeling Update | Submitted | 3 | 2023-10-07 | — | 2022-07-30 |
| 0053 | CDSCO-2022-0053 | Initial Marketing Authorisation | Failed | 1 | 2022-04-26 | 2023-06-17 | 2023-05-14 |
| 0054 | COFEPRIS-2021-0054 | Urgent Safety Restriction | In Progress | 2 | 2022-05-12 | 2024-03-09 | 2022-01-23 |
| 0055 | ANMAT-2020-0055 | Initial Marketing Authorisation | Draft | 0 | 2022-06-16 | — | 2023-05-01 |
| 0056 | TITCK-2024-0056 | Labeling Update | Active | 3 | 2022-06-27 | — | 2022-03-30 |
| 0057 | SFDA-2023-0057 | Type II Variation | Active | 0 | 2023-07-18 | 2023-12-19 | 2023-05-12 |
| 0058 | SAHPRA-2022-0058 | Initial Marketing Authorisation | Pending | 0 | — | — | 2022-01-09 |
| 0059 | Roszdravnadzor-2021-0059 | Response to Questions | Active | 1 | — | — | 2023-04-15 |
| 0060 | MOH-IL-2020-0060 | Safety Update | Overdue | 3 | — | — | 2022-06-13 |
| 0061 | FDA-2024-0061 | Type IA Variation | Draft | 3 | 2023-06-30 | — | 2022-03-18 |
| 0062 | EMA-2023-0062 | Type IB Variation | Draft | 0 | 2023-12-31 | 2023-11-07 | 2023-02-23 |
| 0063 | PMDA-2022-0063 | Renewal | Completed | 0 | — | 2024-05-05 | 2022-02-03 |
| 0064 | NMPA-2021-0064 | Type IB Variation | Approved | 3 | — | 2023-12-21 | 2022-01-28 |
| 0065 | ANVISA-2020-0065 | Type II Variation | Active | 1 | 2022-06-28 | — | 2022-05-02 |
| 0066 | HC-2024-0066 | Urgent Safety Restriction | Draft | 0 | — | — | 2022-11-12 |
| 0067 | TGA-2023-0067 | Labeling Update | Active | 2 | 2023-04-03 | — | 2022-12-15 |
| 0068 | MHRA-2022-0068 | Annual Report | In Progress | 0 | 2023-12-09 | — | 2023-01-20 |
| 0069 | SwissMedic-2021-0069 | Initial Marketing Authorisation | Active | 3 | 2023-11-26 | — | 2022-04-19 |
| 0070 | MFDS-2020-0070 | Safety Update | Failed | 2 | — | — | 2022-11-25 |
| 0071 | TFDA-2024-0071 | Response to Questions | Draft | 2 | — | — | 2022-01-20 |
| 0072 | HSA-2023-0072 | Type IA Variation | Blocked | 0 | 2022-08-25 | 2023-11-18 | 2022-06-10 |
| 0073 | CDSCO-2022-0073 | Initial Marketing Authorisation | Submitted | 0 | 2023-09-29 | — | 2023-03-20 |
| 0074 | COFEPRIS-2021-0074 | Response to Questions | In Progress | 2 | — | 2023-06-11 | 2022-08-15 |
| 0075 | ANMAT-2020-0075 | Type IA Variation | Completed | 3 | 2022-05-11 | 2024-02-03 | 2022-11-11 |
| 0076 | TITCK-2024-0076 | Type IA Variation | In Progress | 2 | 2023-11-17 | 2023-08-02 | 2022-06-29 |
| 0077 | SFDA-2023-0077 | Initial Marketing Authorisation | Pending | 2 | 2024-02-14 | 2023-11-12 | 2022-08-12 |
| 0078 | SAHPRA-2022-0078 | Labeling Update | Approved | 1 | 2023-06-29 | 2023-06-09 | 2022-02-13 |
| 0079 | Roszdravnadzor-2021-0079 | Type II Variation | Approved | 0 | 2022-07-05 | — | 2022-11-27 |
| 0080 | MOH-IL-2020-0080 | Urgent Safety Restriction | In Progress | 0 | 2024-03-22 | — | 2023-04-25 |
| 0081 | FDA-2024-0081 | Urgent Safety Restriction | Active | 1 | 2022-06-17 | — | 2022-03-01 |
| 0082 | EMA-2023-0082 | Labeling Update | Blocked | 1 | 2022-08-09 | — | 2022-09-12 |
| 0083 | PMDA-2022-0083 | Labeling Update | Active | 1 | 2022-12-30 | — | 2022-04-26 |
| 0084 | NMPA-2021-0084 | Urgent Safety Restriction | Submitted | 0 | 2024-03-02 | 2024-07-12 | 2023-03-31 |
| 0085 | ANVISA-2020-0085 | Labeling Update | Failed | 2 | 2024-02-03 | — | 2022-11-21 |
| 0086 | HC-2024-0086 | Type IA Variation | Pending | 3 | 2023-11-30 | 2024-04-07 | 2023-04-08 |
| 0087 | TGA-2023-0087 | Type IB Variation | Approved | 3 | 2022-05-11 | — | 2023-02-05 |
| 0088 | MHRA-2022-0088 | Renewal | Submitted | 0 | 2024-01-14 | — | 2023-03-26 |
| 0089 | SwissMedic-2021-0089 | Type IB Variation | Blocked | 0 | 2023-11-13 | — | 2022-09-18 |
| 0090 | MFDS-2020-0090 | Urgent Safety Restriction | Approved | 3 | — | 2024-01-22 | 2022-04-06 |
| 0091 | TFDA-2024-0091 | Type II Variation | Failed | 3 | 2024-03-02 | 2023-08-19 | 2022-05-19 |
| 0092 | HSA-2023-0092 | Urgent Safety Restriction | Blocked | 0 | 2022-05-19 | 2023-12-14 | 2023-03-17 |
| 0093 | CDSCO-2022-0093 | Response to Questions | In Progress | 2 | — | 2023-12-12 | 2022-12-02 |
| 0094 | COFEPRIS-2021-0094 | Annual Report | Submitted | 2 | — | — | 2023-01-08 |
| 0095 | ANMAT-2020-0095 | Labeling Update | Pending | 3 | — | 2023-09-03 | 2022-06-17 |
| 0096 | TITCK-2024-0096 | Type IB Variation | Completed | 2 | 2022-09-03 | — | 2022-08-01 |
| 0097 | SFDA-2023-0097 | Annual Report | Pending | 3 | 2023-01-01 | — | 2022-03-14 |
| 0098 | SAHPRA-2022-0098 | Urgent Safety Restriction | Active | 0 | — | 2023-11-08 | 2022-06-16 |
| 0099 | Roszdravnadzor-2021-0099 | Type II Variation | Failed | 2 | 2024-02-01 | — | 2023-02-25 |
| 0100 | MOH-IL-2020-0100 | Annual Report | Overdue | 0 | — | — | 2023-05-16 |
Showing 100 of 400 sequences