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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213186
Company: GRANULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAMELTEON RAMELTEON 8MG TABLET;ORAL Prescription AB No No
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-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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 091693 DR REDDYS LABS SA
RAMELTEON RAMELTEON 8MG TABLET;ORAL Prescription No AB 215435 ENALTEC
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 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
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