Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213186
Company: GRANULES

Products on ANDA 213186

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213186

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2020	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
03/28/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/04/2021	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 213186

RAMELTEON

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	091610	ACTAVIS LABS FL INC
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215972	AUROBINDO PHARMA LTD
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	091693	DR REDDYS LABS SA
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	213186	GRANULES
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	212650	I3 PHARMS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215435	INNOGENIX
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	215243	MICRO LABS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	213815	UPSHER SMITH LABS
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	216209	XIROMED
RAMELTEON	RAMELTEON	8MG	TABLET;ORAL	Prescription	No	AB	211567	ZYDUS PHARMS
ROZEREM	RAMELTEON	8MG	TABLET;ORAL	Prescription	Yes	AB	021782	TAKEDA PHARMS USA