{"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:ANDA218900","type":"drug_approval","title":"APPROVED: TOFACITINIB CITRATE (SAPTALIS PHARMS) — original application","summary":"FDA approved ANDA218900 ORIG 1 for SAPTALIS PHARMS (TOFACITINIB CITRATE), SOLUTION. Review: STANDARD.","significance":8,"detectedAt":"2026-07-14T22:18:59.141Z","effectiveDate":"2026-06-09","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA218900","sponsor":"SAPTALIS PHARMS","brand":"TOFACITINIB CITRATE","submissionType":"ORIG","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:NDA208090","type":"supplement_approval","title":"APPROVED: XTAMPZA ER (COLLEGIUM PHARM INC) — REMS","summary":"FDA approved NDA208090 SUPPL 25 for COLLEGIUM PHARM INC (OXYCODONE), CAPSULE, EXTENDED RELEASE. Review: N/A.","significance":5,"detectedAt":"2026-07-14T22:18:59.141Z","effectiveDate":"2026-06-18","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"NDA208090","sponsor":"COLLEGIUM PHARM INC","brand":"XTAMPZA ER","submissionType":"SUPPL","classCode":"REMS","priority":"N/A"}},{"source":"fda-approvals","entityId":"fda-app:ANDA206136","type":"supplement_approval","title":"APPROVED: PIROXICAM (STRIDES PHARMA) — Labeling","summary":"FDA approved ANDA206136 SUPPL 8 for STRIDES PHARMA (PIROXICAM), CAPSULE. Review: STANDARD.","significance":5,"detectedAt":"2026-07-14T22:18:59.141Z","effectiveDate":"2026-06-25","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA206136","sponsor":"STRIDES PHARMA","brand":"PIROXICAM","submissionType":"SUPPL","classCode":"Labeling","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:NDA209184","type":"supplement_approval","title":"APPROVED: INBRIJA (MERZ) — Labeling","summary":"FDA approved NDA209184 SUPPL 13 for MERZ (LEVODOPA), POWDER. Review: STANDARD.","significance":5,"detectedAt":"2026-07-14T22:18:59.141Z","effectiveDate":"2026-07-07","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"NDA209184","sponsor":"MERZ","brand":"INBRIJA","submissionType":"SUPPL","classCode":"Labeling","priority":"STANDARD"}},{"source":"fda-approvals","entityId":"fda-app:ANDA200465","type":"supplement_approval","title":"APPROVED: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (MYLAN) — Labeling","summary":"FDA approved ANDA200465 SUPPL 10 for MYLAN (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM), TABLET. Review: STANDARD.","significance":5,"detectedAt":"2026-07-14T22:18:59.141Z","effectiveDate":"2026-06-25","sourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/","detail":{"applicationNumber":"ANDA200465","sponsor":"MYLAN","brand":"AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM","submissionType":"SUPPL","classCode":"Labeling","priority":"STANDARD"}}]}