FDA ANDA · ANDA076485
ISOTRETINOIN
Sponsor: UPSHER SMITH LABS
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APPLICATION
ANDA076485
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-19
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MYORISANPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
MYORISANPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
MYORISANPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
MYORISANPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 49AP
2026-08-21Labeling · Supplement 51 · standardAP
2026-02-09REMS · Supplement 41AP
2025-06-03Labeling · Supplement 40 · standardAP
2024-02-16Labeling · Supplement 34 · standardAP
2024-02-16Labeling · Supplement 39 · standardAP
2023-06-23REMS · Supplement 38AP
2022-10-06REMS · Supplement 33AP
2022-08-24Labeling · Supplement 30 · standardAP
2021-11-08Labeling · Supplement 28 · standardAP
2021-10-08REMS · Supplement 27AP
2020-12-09REMS · Supplement 25AP
2018-08-31Labeling · Supplement 21 · standardAP
2018-05-02Labeling · Supplement 18 · standardAP
2018-04-23REMS · Supplement 19AP
2017-06-17REMS · Supplement 15AP
2016-07-08REMS · Supplement 13AP
2016-02-04REMS · Supplement 12AP
2015-09-03REMS · Supplement 10AP
2014-12-13Labeling · Supplement 4 · standardAP
2012-04-30REMS · Supplement 3AP
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