Data as of 2026-07-12 — 788,886 rows loaded

020607

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription AB ✓
002 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription AB ✓ ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 43 AP 2024-11-21 LABELING STANDARD
SUPPL 41 AP 2022-12-22 LABELING STANDARD
SUPPL 40 AP 2022-08-26 LABELING STANDARD
SUPPL 39 AP 2021-08-02 LABELING STANDARD
SUPPL 38 AP 2021-04-28 LABELING STANDARD
SUPPL 36 AP 2020-09-24 LABELING STANDARD
SUPPL 33 AP 2020-07-28 LABELING STANDARD
SUPPL 31 AP 2016-05-09 LABELING STANDARD
SUPPL 21 AP 2015-04-01 LABELING STANDARD
SUPPL 28 AP 2014-09-03 LABELING STANDARD
SUPPL 25 AP 2013-03-07 LABELING STANDARD
SUPPL 26 AP 2013-02-08 MANUF (CMC) STANDARD
SUPPL 16 AP 2010-12-21 LABELING UNKNOWN
SUPPL 13 AP 2009-09-11 LABELING STANDARD
SUPPL 14 AP 2009-02-25 LABELING 901 REQUIRED
SUPPL 10 AP 2007-08-24 LABELING STANDARD
SUPPL 9 AP 2006-01-25 LABELING STANDARD
SUPPL 8 AP 2005-07-08 LABELING STANDARD
SUPPL 7 AP 2002-05-20 MANUF (CMC) STANDARD
SUPPL 5 AP 2000-10-03 LABELING STANDARD
SUPPL 4 AP 1999-02-22 LABELING STANDARD
SUPPL 3 AP 1998-07-20 MANUF (CMC) STANDARD
SUPPL 1 AP 1998-04-15 MANUF (CMC) STANDARD
SUPPL 2 AP 1998-03-16 MANUF (CMC) STANDARD
ORIG 1 AP 1997-12-24 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2024-11-25 Label SUPPL-43 0
2024-11-25 Medication Guide SUPPL-43 0
2024-11-22 Letter SUPPL-43 0
2022-12-27 Label SUPPL-41 0
2022-12-23 Letter SUPPL-41 0
2022-08-30 Label SUPPL-40 0
2022-08-29 Letter SUPPL-40 0
2021-08-05 Letter SUPPL-39 0
2021-08-03 Label SUPPL-39 0
2021-05-04 Label SUPPL-38 0
2021-04-29 Letter SUPPL-38 0
2020-09-25 Letter SUPPL-36 0
2020-09-25 Label SUPPL-36 0
2020-07-30 Label SUPPL-33 0
2020-07-29 Letter SUPPL-33 0
2016-05-12 Letter SUPPL-31 0
2016-05-11 Label SUPPL-31 0
2015-04-03 Letter SUPPL-21 0
2015-04-02 Label SUPPL-21 0
2014-09-09 Label SUPPL-28 0
2014-09-05 Letter SUPPL-28 0
2013-03-08 Letter SUPPL-25 0
2013-03-08 Label SUPPL-25 0
2010-12-22 Letter SUPPL-16 0
2010-12-22 Label SUPPL-16 0
2009-11-10 Letter SUPPL-13 0
2009-10-06 Label SUPPL-13 0
2009-03-17 Label SUPPL-14 0
2009-02-27 Letter SUPPL-14 0
2007-08-27 Label SUPPL-10 0
2007-08-27 Letter SUPPL-10 0
2006-01-30 Letter SUPPL-9 0
2006-01-25 Label SUPPL-9 0
2005-07-15 Letter SUPPL-8 0
2003-08-08 Review ORIG-1 0
1999-02-22 Review SUPPL-4 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "43", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "18"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "14"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "43", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "40", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "21", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "020607", "ProductNo": "002", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "020607", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "020607", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "020607", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "43"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020607", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "020607", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "020607", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020607"}