FDA ANDA · ANDA075945
AMNESTEEM
isotretinoin
Sponsor: MYLAN PHARMS INC
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APPLICATION
ANDA075945
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-08
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMNESTEEMPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
AMNESTEEMPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
AMNESTEEMPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
AMNESTEEMPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 53AP
2026-09-15Labeling · Supplement 45 · standardAP
2026-08-21Labeling · Supplement 54 · standardAP
2026-02-09REMS · Supplement 49AP
2025-03-17Manufacturing (CMC) · Supplement 48 · unknownAP
2023-03-24REMS · Supplement 46AP
2022-10-06REMS · Supplement 44AP
2022-08-23Labeling · Supplement 43 · standardAP
2021-11-08Labeling · Supplement 41 · standardAP
2021-10-08REMS · Supplement 40AP
2020-12-09REMS · Supplement 39AP
2018-08-31Labeling · Supplement 37 · standardAP
2018-05-02Labeling · Supplement 35 · standardAP
2018-04-23REMS · Supplement 36AP
2017-06-17REMS · Supplement 34AP
2016-07-08REMS · Supplement 33AP
2016-02-04REMS · Supplement 32AP
2015-12-16Labeling · Supplement 27AP
2015-12-16Manufacturing (CMC) · Supplement 28 · unknownAP
2015-09-03Labeling · Supplement 31 · standardAP
2012-04-12REMS · Supplement 25AP
2012-04-12REMS · Supplement 17AP
2012-04-12REMS · Supplement 26AP
2012-04-12REMS · Supplement 16AP
2012-04-12REMS · Supplement 22AP
2010-10-22REMS · Supplement 15AP
2007-02-06Labeling · Supplement 10AP
2005-08-25Labeling · Supplement 6AP
2005-08-25Labeling · Supplement 5AP
2005-08-12Labeling · Supplement 9AP
2003-02-27Labeling · Supplement 2AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →