Data as of 2026-09-09 — 792,868 rows loaded

203335

ANDA DR REDDYS LABS SA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;50MG;40MG;30MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 5 AP 2018-09-18 REMS
ORIG 1 AP 2015-10-30 UNKNOWN
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-02 REMS ORIG-1 0
2015-11-04 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-09-09 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-08 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-04 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-09-01 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-31 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-28 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-26 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-24 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-21 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-20 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-19 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-18 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-17 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-14 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-13 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-12 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-11 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-10 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-08-07 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-08-05 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-31 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-29 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-27 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-24 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-23 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-22 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-17 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-15 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-14 submission_property_type UPDATE {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 submission_property_type INSERT {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "203335", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "203335", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "203335", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "203335", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "203335"}