Data as of 2026-07-12 — 788,886 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
2026-07-12 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"}