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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211568
Company: ZYDUS PHARMS

REMS

Products on ANDA 211568

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 211568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211568

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
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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