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

018817

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 CALAN VERAPAMIL HYDROCHLORIDE TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 CALAN VERAPAMIL HYDROCHLORIDE TABLET;ORAL 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
003 CALAN VERAPAMIL HYDROCHLORIDE TABLET;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued
004 CALAN VERAPAMIL HYDROCHLORIDE TABLET;ORAL 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 35 AP 2021-11-19 LABELING STANDARD
SUPPL 33 AP 2017-09-14 LABELING STANDARD
SUPPL 32 AP 2016-08-24 LABELING STANDARD
SUPPL 31 AP 2013-10-25 LABELING STANDARD
SUPPL 29 AP 2013-02-13 MANUF (CMC) STANDARD
SUPPL 27 AP 2011-11-02 LABELING UNKNOWN
SUPPL 24 AP 2011-06-29 LABELING UNKNOWN
SUPPL 22 AP 2010-04-13 LABELING UNKNOWN
SUPPL 21 AP 2009-07-09 LABELING STANDARD
SUPPL 19 AP 1998-01-13 LABELING STANDARD
SUPPL 18 AP 1996-05-14 MANUF (CMC) STANDARD
SUPPL 17 AP 1996-02-07 MANUF (CMC) STANDARD
SUPPL 16 AP 1994-11-04 LABELING STANDARD
SUPPL 15 AP 1991-09-27 LABELING
SUPPL 14 AP 1991-08-12 LABELING
SUPPL 13 AP 1990-02-14 LABELING
SUPPL 12 AP 1988-04-13 LABELING
SUPPL 11 AP 1988-02-23 LABELING
SUPPL 7 AP 1988-02-23 EFFICACY
SUPPL 10 AP 1987-04-29 LABELING
SUPPL 9 AP 1987-04-29 LABELING
SUPPL 8 AP 1987-04-29 MANUF (CMC) STANDARD
SUPPL 3 AP 1986-12-16 EFFICACY
SUPPL 4 AP 1986-10-20 MANUF (CMC) STANDARD
SUPPL 6 AP 1986-06-27 LABELING
SUPPL 5 AP 1986-05-06 MANUF (CMC) STANDARD
SUPPL 1 AP 1985-06-04 MANUF (CMC) STANDARD
ORIG 1 AP 1984-09-10 TYPE 5 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2022-06-01 Label SUPPL-35 0
2021-11-23 Letter SUPPL-35 0
2017-09-19 Letter SUPPL-33 0
2017-09-18 Label SUPPL-33 0
2016-08-24 Letter SUPPL-32 0
2013-10-31 Label SUPPL-31 0
2013-10-28 Letter SUPPL-31 0
2011-11-07 Letter SUPPL-27 0
2011-11-04 Label SUPPL-27 0
2011-07-05 Letter SUPPL-24 0
2011-06-30 Label SUPPL-24 0
2010-04-19 Letter SUPPL-22 0
2010-04-19 Label SUPPL-22 0
2009-07-23 Label SUPPL-21 0
2009-07-17 Letter SUPPL-21 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "24", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "13", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "27", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "35", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "22", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "16", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "32", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "8"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "11", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "19", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "12", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "14", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "33", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "15", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "7"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "31", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "21", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "18", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "17", "ActionTypes_LookupID": "42"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "37"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "29", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "33"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "33"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "35", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "33", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "32", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "31", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "29", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "27", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "24", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "22", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "18", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "17", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "018817", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "018817", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "018817", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "018817", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "11"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "12"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "13"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "14"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "15"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "16"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "17"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "18"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "19"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "21"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "22"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "24"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "27"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "29"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "31"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "32"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "33"}
2026-07-12 submissions INSERT {"ApplNo": "018817", "SubmissionType": "SUPPL", "SubmissionNo": "35"}
2026-07-12 products INSERT {"ApplNo": "018817", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "018817", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "018817", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "018817", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "018817"}