FDA ANDA · ANDA202099
ZENATANE
isotretinoin
Sponsor: DR REDDYS LABS LTD
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APPLICATION
ANDA202099
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-25
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZENATANEPrescription
ISOTRETINOIN 30MG · CAPSULE · ORAL
ZENATANEPrescription
ISOTRETINOIN 20MG · CAPSULE · ORAL
ZENATANEPrescription
ISOTRETINOIN 40MG · CAPSULE · ORAL
ZENATANEPrescription
ISOTRETINOIN 10MG · CAPSULE · ORAL
Approval history
2026-10-07REMS · Supplement 43AP
2026-08-21Labeling · Supplement 44 · standardAP
2026-02-09REMS · Supplement 39AP
2023-03-24REMS · Supplement 33AP
2022-10-06REMS · Supplement 31AP
2022-08-23Labeling · Supplement 28 · standardAP
2022-08-04Manufacturing (CMC) · Supplement 29 · unknownAP
2021-11-09Labeling · Supplement 23 · standardAP
2021-10-08REMS · Supplement 24AP
2020-12-09REMS · Supplement 21AP
2020-11-16Labeling · Supplement 20 · standardAP
2018-08-31Labeling · Supplement 15 · standardAP
2018-05-02Labeling · Supplement 11 · standardAP
2018-04-23REMS · Supplement 12AP
2017-06-17REMS · Supplement 9AP
2016-07-08REMS · Supplement 7AP
2016-02-04REMS · Supplement 5AP
2015-09-03REMS · Supplement 4AP
2015-02-23Manufacturing (CMC) · Supplement 2 · unknownAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →