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

019152

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CALAN SR VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
002 CALAN SR VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
003 CALAN SR VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued AB ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 45 AP 2020-05-22 MANUF (CMC) N/A
SUPPL 44 AP 2019-10-28 LABELING STANDARD
SUPPL 41 AP 2017-09-14 LABELING STANDARD
SUPPL 39 AP 2016-08-24 LABELING STANDARD
SUPPL 38 AP 2013-10-28 LABELING STANDARD
SUPPL 37 AP 2013-01-10 MANUF (CMC) STANDARD
SUPPL 35 AP 2011-12-01 LABELING UNKNOWN
SUPPL 33 AP 2010-03-31 LABELING UNKNOWN
SUPPL 32 AP 2009-07-01 LABELING STANDARD
SUPPL 30 AP 2002-11-26 MANUF (CMC) STANDARD
SUPPL 26 AP 2001-09-28 LABELING STANDARD
SUPPL 29 AP 2001-02-14 MANUF (CMC) STANDARD
SUPPL 28 AP 2001-02-12 MANUF (CMC) STANDARD
SUPPL 27 AP 2000-07-14 MANUF (CMC) STANDARD
SUPPL 25 AP 1998-12-11 MANUF (CMC) STANDARD
SUPPL 23 AP 1998-01-13 LABELING STANDARD
SUPPL 24 AP 1997-05-16 MANUF (CMC) STANDARD
SUPPL 20 AP 1995-03-17 MANUF (CMC) STANDARD
SUPPL 15 AP 1994-07-28 MANUF (CMC) STANDARD
SUPPL 22 AP 1993-11-05 MANUF (CMC) STANDARD
SUPPL 19 AP 1992-09-23 MANUF (CMC) STANDARD
SUPPL 17 AP 1992-09-03 LABELING
SUPPL 16 AP 1992-05-04 MANUF (CMC) STANDARD
SUPPL 14 AP 1991-03-06 MANUF (CMC) STANDARD
SUPPL 6 AP 1991-03-06 MANUF (CMC) STANDARD
SUPPL 13 AP 1990-01-19 MANUF (CMC) STANDARD
SUPPL 9 AP 1989-12-15 EFFICACY
SUPPL 7 AP 1989-08-08 MANUF (CMC) STANDARD
SUPPL 10 AP 1989-06-14 MANUF (CMC) STANDARD
SUPPL 12 AP 1989-05-17 MANUF (CMC) STANDARD
SUPPL 11 AP 1989-03-30 MANUF (CMC) STANDARD
SUPPL 4 AP 1988-11-30 MANUF (CMC) STANDARD
SUPPL 3 AP 1988-11-30 MANUF (CMC) STANDARD
SUPPL 2 AP 1988-11-30 MANUF (CMC) STANDARD
SUPPL 8 AP 1988-09-22 LABELING
SUPPL 5 AP 1988-07-20 LABELING
SUPPL 1 AP 1987-09-24 MANUF (CMC) STANDARD
ORIG 1 AP 1986-12-16 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2021-04-07 Label SUPPL-45 0
2021-03-19 Letter SUPPL-45 0
2019-10-29 Label SUPPL-44 0
2019-10-29 Letter SUPPL-44 0
2017-09-19 Letter SUPPL-41 0
2017-09-18 Label SUPPL-41 0
2017-02-23 Label SUPPL-39 0
2016-08-24 Letter SUPPL-39 0
2013-10-28 Label SUPPL-38 0
2013-10-28 Letter SUPPL-38 0
2011-12-05 Letter SUPPL-35 0
2011-12-02 Label SUPPL-35 0
2010-04-04 Label SUPPL-33 0
2010-04-02 Letter SUPPL-33 0
2009-07-09 Label SUPPL-32 0
2009-07-08 Letter SUPPL-32 0
2002-11-26 Letter SUPPL-30 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "41", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "23", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "26", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "38", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "39", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "44", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "7"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "45", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "28", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "37", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "30", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "34"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "25", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "20", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "44", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "41", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "39", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "38", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "37", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "30", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "28", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "25", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "20", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "19", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "16", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "15", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "14", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "13", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "12", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "11", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 te INSERT {"ApplNo": "019152", "ProductNo": "003", "TECode": "AB"}
2026-07-12 te INSERT {"ApplNo": "019152", "ProductNo": "001", "TECode": "AB"}
2026-07-12 marketing_status INSERT {"ApplNo": "019152", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "019152", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "019152", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "20"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "23"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "25"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "26"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "28"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "30"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "37"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "38"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "39"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "41"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "44"}
2026-07-12 submissions INSERT {"ApplNo": "019152", "SubmissionType": "SUPPL", "SubmissionNo": "45"}
2026-07-12 products INSERT {"ApplNo": "019152", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "019152", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "019152", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "019152"}