Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213571
Company: UPSHER SMITH LABS

• REMS

Products on ANDA 213571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2021	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-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
03/24/2023	SUPPL-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/06/2022	SUPPL-6	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/24/2022	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/08/2021	SUPPL-1	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 213571

ISOTRETINOIN

CAPSULE;ORAL; 40MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABSORICA	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	Yes	AB2	021951	SUN PHARM INDS INC
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB2	205063	ACTAVIS LABS FL
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB2	216097	AMNEAL PHARMS NY
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB2	218194	AUROBINDO PHARMA
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB2	213571	UPSHER SMITH LABS
ISOTRETINOIN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB2	216633	ZYDUS PHARMS