FDA ANDA · ANDA207792
ISOTRETINOIN
Sponsor: AMNEAL PHARMS NY
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APPLICATION
ANDA207792
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-29
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ISOTRETINOINPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ISOTRETINOINPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 38AP
2026-08-21Labeling · Supplement 36 · standardAP
2026-02-09REMS · Supplement 30AP
2024-06-26Labeling · Supplement 22 · standardAP
2023-03-24REMS · Supplement 24AP
2022-10-06REMS · Supplement 20AP
2022-08-24Labeling · Supplement 19 · standardAP
2021-11-08Labeling · Supplement 15 · standardAP
2021-10-08REMS · Supplement 14AP
2020-12-09REMS · Supplement 11AP
2018-08-31Labeling · Supplement 5 · standardAP
2018-05-02Labeling · Supplement 2 · standardAP
2018-04-23REMS · Supplement 3AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →