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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076485
Company: DOUGLAS PHARMS

REMS

Products on ANDA 076485

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/076485Orig1s003.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2022	SUPPL-33	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/24/2022	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
11/08/2021	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
10/08/2021	SUPPL-27	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/09/2020	SUPPL-25	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/31/2018	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
04/23/2018	SUPPL-19	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/02/2018	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/17/2017	SUPPL-15	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/08/2016	SUPPL-13	REMS-Modified		Label is not available on this site.
02/04/2016	SUPPL-12	REMS-Modified		Label is not available on this site.
09/03/2015	SUPPL-10	REMS-Modified		Label is not available on this site.
12/13/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/30/2012	SUPPL-3	REMS-Modified		Label is not available on this site.

Therapeutic Equivalents for ANDA 076485

MYORISAN

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
MYORISAN	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	No	AB1	076485	DOUGLAS PHARMS
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
MYORISAN	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	No	AB1	076485	DOUGLAS PHARMS
ZENATANE	ISOTRETINOIN	20MG	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
MYORISAN	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	No	AB1	076485	DOUGLAS PHARMS
ZENATANE	ISOTRETINOIN	40MG	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
MYORISAN	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	076485	DOUGLAS PHARMS
ZENATANE	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	No	AB1	202099	DR REDDYS LABS LTD

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