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

074817

ANDA CHARTWELL RX
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 INVAGESIC ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 385MG;30MG;25MG Discontinued
002 INVAGESIC FORTE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE TABLET;ORAL 770MG;60MG;50MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 6 AP 2024-11-21 LABELING STANDARD
SUPPL 5 AP 2024-10-11 LABELING STANDARD
SUPPL 3 AP 2021-04-28 LABELING STANDARD
SUPPL 2 AP 1998-08-19 MANUF (CMC)
SUPPL 1 AP 1997-08-06 MANUF (CMC)
ORIG 1 AP 1996-11-27
Documents (latest 100)
DateTypeSubmissionTitle / Link
1997-12-02 Review ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "3", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "19"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "30"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "30"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "3", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "074817", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "074817", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "3"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "074817", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "074817", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "074817", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "074817"}