{"source":"fda-approvals","note":"Free 5-item preview. The full feed is $0.05/call at GET /v1/fda-approvals/changes.","question":"Which FDA drug application approval actions happened since T, and which are new drugs vs supplements?","sample":[{"source":"fda-approvals","entityId":"fda-app:ANDA209624","type":"drug_approval","title":"APPROVED: BOSUTINIB (MSN) — original application","summary":"FDA approved ANDA209624 ORIG 1 for MSN (BOSUTINIB MONOHYDRATE), TABLET. Review: STANDARD.","significance":8,"detectedAt":"2026-07-20T00:28:29.374Z","effectiveDate":"2026-06-12","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA209624","sponsor":"MSN","brand":"BOSUTINIB","submissionType":"ORIG","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:ANDA209286","type":"supplement_approval","title":"APPROVED: DIVALPROEX SODIUM (LUPIN) — Labeling","summary":"FDA approved ANDA209286 SUPPL 20 for LUPIN (DIVALPROEX SODIUM), TABLET, EXTENDED RELEASE. Review: STANDARD.","significance":5,"detectedAt":"2026-07-20T00:28:29.374Z","effectiveDate":"2026-06-11","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA209286","sponsor":"LUPIN","brand":"DIVALPROEX SODIUM","submissionType":"SUPPL","classCode":"Labeling","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:ANDA202104","type":"supplement_approval","title":"APPROVED: MORPHINE SULFATE (UPSHER SMITH LABS) — REMS","summary":"FDA approved ANDA202104 SUPPL 29 for UPSHER SMITH LABS (MORPHINE SULFATE), CAPSULE, EXTENDED RELEASE. Review: standard.","significance":5,"detectedAt":"2026-07-18T23:39:13.866Z","effectiveDate":"2026-06-18","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA202104","sponsor":"UPSHER SMITH LABS","brand":"MORPHINE SULFATE","submissionType":"SUPPL","classCode":"REMS"}},{"source":"fda-approvals","entityId":"fda-app:ANDA207429","type":"supplement_approval","title":"APPROVED: SOTALOL HYDROCHLORIDE (REGCON HOLDINGS) — Labeling","summary":"FDA approved ANDA207429 SUPPL 8 for REGCON HOLDINGS (SOTALOL HYDROCHLORIDE), TABLET. Review: STANDARD.","significance":5,"detectedAt":"2026-07-18T23:39:13.866Z","effectiveDate":"2026-06-05","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA207429","sponsor":"REGCON HOLDINGS","brand":"SOTALOL HYDROCHLORIDE","submissionType":"SUPPL","classCode":"Labeling","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:ANDA205057","type":"supplement_approval","title":"APPROVED: TAPENTADOL HYDROCHLORIDE (HIKMA) — REMS","summary":"FDA approved ANDA205057 SUPPL 3 for HIKMA (TAPENTADOL HYDROCHLORIDE), TABLET. Review: standard.","significance":5,"detectedAt":"2026-07-18T23:39:13.866Z","effectiveDate":"2026-06-18","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA205057","sponsor":"HIKMA","brand":"TAPENTADOL HYDROCHLORIDE","submissionType":"SUPPL","classCode":"REMS"}}]}