FDA ANDA · ANDA076135
CLARAVIS
isotretinoin
Sponsor: TEVA PHARMS USA
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APPLICATION
ANDA076135
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-11
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLARAVISPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
CLARAVISPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
CLARAVISPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 70AP
2026-08-21Labeling · Supplement 69 · standardAP
2026-02-09REMS · Supplement 62AP
2024-03-04Labeling · Supplement 56 · standardAP
2023-03-24REMS · Supplement 60AP
2022-10-06REMS · Supplement 58AP
2022-08-23Labeling · Supplement 55 · standardAP
2021-11-08Labeling · Supplement 53 · standardAP
2021-10-08REMS · Supplement 52AP
2020-12-09REMS · Supplement 50AP
2018-08-31Labeling · Supplement 43 · standardAP
2018-05-02Labeling · Supplement 41 · standardAP
2018-04-23REMS · Supplement 42AP
2017-06-17REMS · Supplement 38AP
2016-07-08REMS · Supplement 37AP
2016-02-04REMS · Supplement 36AP
2015-09-03REMS · Supplement 35AP
2015-07-20Labeling · Supplement 30 · standardAP
2012-04-12REMS · Supplement 29AP
2010-10-22REMS · Supplement 18AP
2010-03-25Labeling · Supplement 17AP
2007-11-02Labeling · Supplement 15AP
2007-02-02Labeling · Supplement 11AP
2007-02-02Labeling · Supplement 14AP
2006-05-11Labeling · Supplement 5AP
2005-08-12Labeling · Supplement 8AP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →