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

020552

NDA PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 COVERA-HS VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG Discontinued
002 COVERA-HS VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 240MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 10 AP 2017-09-14 LABELING STANDARD
SUPPL 9 AP 2016-08-24 LABELING STANDARD
SUPPL 7 AP 2011-11-02 LABELING UNKNOWN
SUPPL 6 AP 2010-04-13 LABELING UNKNOWN
SUPPL 5 AP 2009-06-29 LABELING STANDARD
SUPPL 2 AP 2003-01-31 LABELING STANDARD
SUPPL 1 AP 1998-01-13 LABELING STANDARD
ORIG 1 AP 1996-02-26 TYPE 5 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2017-09-19 Letter SUPPL-10 0
2017-09-18 Label SUPPL-10 0
2016-08-24 Letter SUPPL-9 0
2011-11-07 Letter SUPPL-7 0
2011-11-04 Label SUPPL-7 0
2010-04-30 Label SUPPL-6 0
2010-04-21 Letter SUPPL-6 0
2009-07-07 Letter SUPPL-5 0
2009-06-30 Label SUPPL-5 0
2004-06-02 Letter SUPPL-2 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "10", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "9", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "10", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "9", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "020552", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "020552", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "9"}
2026-07-12 submissions INSERT {"ApplNo": "020552", "SubmissionType": "SUPPL", "SubmissionNo": "10"}
2026-07-12 products INSERT {"ApplNo": "020552", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "020552", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "020552"}