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

091670

ANDA DR REDDYS LABS SA
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 8 AP 2021-04-28 LABELING STANDARD
SUPPL 7 AP 2021-03-04 LABELING STANDARD
SUPPL 6 AP 2021-02-26 LABELING STANDARD
SUPPL 5 AP 2019-10-08 LABELING STANDARD
SUPPL 4 AP 2018-09-20 LABELING STANDARD
SUPPL 2 AP 2018-09-18 REMS
ORIG 1 AP 2011-03-16
Documents (latest 100)
DateTypeSubmissionTitle / Link
2023-11-02 REMS ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "4", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "2", "ActionTypes_LookupID": "57"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "27"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "27"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "4", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "2", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "091670", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "091670", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "4"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "SUPPL", "SubmissionNo": "2"}
2026-07-12 submissions INSERT {"ApplNo": "091670", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "091670", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "091670"}