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

019268

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CYTOTEC MISOPROSTOL TABLET;ORAL 0.2MG Prescription AB ✓ ✓
003 CYTOTEC MISOPROSTOL TABLET;ORAL 0.1MG Prescription AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 51 AP 2018-02-28 LABELING STANDARD
SUPPL 49 AP 2016-12-19 LABELING STANDARD
SUPPL 48 AP 2013-02-08 MANUF (CMC) PRIORITY
SUPPL 47 AP 2012-11-19 LABELING STANDARD
SUPPL 41 AP 2009-09-11 LABELING STANDARD
SUPPL 40 AP 2003-08-13 LABELING STANDARD
SUPPL 39 AP 2003-08-13 LABELING STANDARD
SUPPL 38 AP 2002-07-01 MANUF (CMC) PRIORITY
SUPPL 37 AP 2002-04-17 LABELING STANDARD
SUPPL 36 AP 2000-10-19 MANUF (CMC) PRIORITY
SUPPL 35 AP 2000-10-19 MANUF (CMC) PRIORITY
SUPPL 31 AP 2000-06-22 LABELING STANDARD
SUPPL 33 AP 2000-01-07 MANUF (CMC) PRIORITY
SUPPL 32 AP 1999-08-11 MANUF (CMC) PRIORITY
SUPPL 30 AP 1998-12-03 MANUF (CMC) PRIORITY
SUPPL 29 AP 1998-10-15 MANUF (CMC) PRIORITY
SUPPL 28 AP 1998-10-15 MANUF (CMC) PRIORITY
SUPPL 27 AP 1998-07-14 MANUF (CMC) PRIORITY
SUPPL 23 AP 1997-08-13 LABELING STANDARD
SUPPL 26 AP 1997-07-30 MANUF (CMC) PRIORITY
SUPPL 25 AP 1997-04-10 MANUF (CMC) PRIORITY
SUPPL 22 AP 1996-06-11 MANUF (CMC) PRIORITY
SUPPL 24 AP 1996-06-10 MANUF (CMC) PRIORITY
SUPPL 18 AP 1994-05-31 MANUF (CMC) PRIORITY
SUPPL 17 AP 1993-05-10 MANUF (CMC) PRIORITY
SUPPL 16 AP 1992-10-28 MANUF (CMC) PRIORITY
SUPPL 15 AP 1991-07-29 LABELING
SUPPL 9 AP 1991-06-21 MANUF (CMC) PRIORITY
SUPPL 14 AP 1991-04-23 LABELING
SUPPL 12 AP 1990-09-21 MANUF (CMC) PRIORITY
SUPPL 13 AP 1990-09-06 LABELING
SUPPL 6 AP 1990-07-16 MANUF (CMC) PRIORITY
SUPPL 7 AP 1990-05-09 MANUF (CMC) PRIORITY
SUPPL 10 AP 1990-04-05 LABELING
SUPPL 8 AP 1990-04-05 LABELING
SUPPL 4 AP 1989-06-27 MANUF (CMC) PRIORITY
SUPPL 2 AP 1989-04-18 MANUF (CMC) PRIORITY
SUPPL 1 AP 1989-02-08 MANUF (CMC) PRIORITY
ORIG 1 AP 1988-12-27 TYPE 1 PRIORITY
Documents (latest 100)
DateTypeSubmissionTitle / Link
2018-03-01 Label SUPPL-51 0
2018-03-01 Letter SUPPL-51 0
2016-12-19 Label SUPPL-49 0
2016-12-19 Letter SUPPL-49 0
2012-11-26 Label SUPPL-47 0
2012-11-21 Letter SUPPL-47 0
2011-12-16 Review ORIG-1 0
2009-11-12 Letter SUPPL-41 0
2009-10-06 Label SUPPL-41 0
2005-07-29 Other Important Information from FDA ORIG-1 0
2003-08-14 Letter SUPPL-39 0
2003-08-14 Letter SUPPL-40 0
2002-04-17 Label SUPPL-37 0
2002-04-17 Letter SUPPL-37 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "40", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "51", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "49", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "47", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "48", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "36", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "51", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "49", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "48", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "47", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "36", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "26", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "019268", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "019268", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "019268", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "019268", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "36"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "40"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "47"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "48"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "49"}
2026-07-12 submissions INSERT {"ApplNo": "019268", "SubmissionType": "SUPPL", "SubmissionNo": "51"}
2026-07-12 products INSERT {"ApplNo": "019268", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "019268", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "019268"}