FDA ANDA · ANDA076356
CLARAVIS
isotretinoin
Sponsor: TEVA PHARMS USA
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APPLICATION
ANDA076356
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-11
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLARAVISPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 64AP
2026-08-21Labeling · Supplement 63 · standardAP
2026-02-09REMS · Supplement 57AP
2024-03-04Labeling · Supplement 51 · standardAP
2023-03-24REMS · Supplement 55AP
2022-10-06REMS · Supplement 53AP
2022-08-23Labeling · Supplement 50 · standardAP
2021-11-08Labeling · Supplement 48 · standardAP
2021-10-08REMS · Supplement 47AP
2020-12-09REMS · Supplement 45AP
2018-08-31Labeling · Supplement 40 · standardAP
2018-05-02Labeling · Supplement 38 · standardAP
2018-04-23REMS · Supplement 39AP
2017-06-17REMS · Supplement 35AP
2016-07-08REMS · Supplement 34AP
2016-02-04REMS · Supplement 33AP
2015-09-03REMS · Supplement 32AP
2015-07-20Labeling · Supplement 27 · standardAP
2012-04-12REMS · Supplement 26AP
2010-10-22REMS · Supplement 17AP
2010-03-25Labeling · Supplement 16AP
2007-11-02Labeling · Supplement 13AP
2007-02-02Labeling · Supplement 9AP
2007-02-02Labeling · Supplement 12AP
2005-08-12Labeling · Supplement 6AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →