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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207792
Company: AMNEAL PHARMS NY

REMS

Products on ANDA 207792

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	AB1	No	No
ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	AB1	No	No
ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	AB1	No	No
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2026	SUPPL-30	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/24/2023	SUPPL-24	REMS - MODIFIED - D-N-A		Label is not available on this site.
06/26/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/06/2022	SUPPL-20	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/24/2022	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/08/2021	SUPPL-15	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/08/2021	SUPPL-14	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/09/2020	SUPPL-11	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/31/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/23/2018	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/02/2018	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207792

ISOTRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMNESTEEM	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	075945	MYLAN PHARMS INC
CLARAVIS	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	076356	TEVA PHARMS USA
ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	207792	AMNEAL PHARMS NY
ISOTRETINOIN	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	211568	ZYDUS PHARMS
MYORISAN	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	076485	UPSHER SMITH LABS
ZENATANE	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	202099	DR REDDYS LABS LTD

CAPSULE;ORAL; 20MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMNESTEEM	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	075945	MYLAN PHARMS INC
CLARAVIS	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	076135	TEVA PHARMS USA
ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	207792	AMNEAL PHARMS NY
ISOTRETINOIN	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	211568	ZYDUS PHARMS
MYORISAN	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	076485	UPSHER SMITH LABS
ZENATANE	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	202099	DR REDDYS LABS LTD

CAPSULE;ORAL; 30MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMNESTEEM	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	075945	MYLAN PHARMS INC
CLARAVIS	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	076135	TEVA PHARMS USA
ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	207792	AMNEAL PHARMS NY
ISOTRETINOIN	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	211568	ZYDUS PHARMS
MYORISAN	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	076485	UPSHER SMITH LABS
ZENATANE	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	202099	DR REDDYS LABS LTD

CAPSULE;ORAL; 40MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMNESTEEM	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	075945	MYLAN PHARMS INC
CLARAVIS	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	076135	TEVA PHARMS USA
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	207792	AMNEAL PHARMS NY
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	211568	ZYDUS PHARMS
MYORISAN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	076485	UPSHER SMITH LABS
ZENATANE	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	202099	DR REDDYS LABS LTD

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