FDA ANDA · ANDA220336
ISOTRETINOIN
Sponsor: AUROBINDO PHARMA LTD
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APPLICATION
ANDA220336
TYPE
ANDA
ORIGINAL APPROVAL
2026-09-10
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
Approval history
2026-10-07REMS · Supplement 1AP
2026-09-10UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →