Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091610
Company: ACTAVIS LABS FL INC
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
08/19/2015 ORIG-1 Approval

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
ROZEREM RAMELTEON 8MG TABLET;ORAL Prescription Yes AB 021782 TAKEDA PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English