Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021476
Company: SUNOVION PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUNESTA ESZOPICLONE 1MG TABLET;ORAL Prescription AB Yes No
LUNESTA ESZOPICLONE 2MG TABLET;ORAL Prescription AB Yes No
LUNESTA ESZOPICLONE 3MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021476ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2019 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s037ltr.pdf
11/07/2018 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021476Orig1s036ltr.pdf
08/27/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/03/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/15/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s030ltr.pdf
05/29/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/03/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021476Orig1s028ltr.pdf
02/16/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/10/2012 SUPPL-26 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf
04/04/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/10/2012 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476Orig1s024,s026ltr.pdf
01/26/2012 SUPPL-21 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021476s021ltr.pdf
09/30/2009 SUPPL-15 Labeling

Label is not available on this site.

04/06/2009 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021476s012ltr.pdf
04/23/2009 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

01/29/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s008ltr.pdf
01/29/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021476s005ltr.pdf
05/23/2006 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s037lbl.pdf
11/07/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf
05/15/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf
02/03/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf
10/10/2012 SUPPL-26 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
04/06/2009 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf
01/29/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
01/29/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
12/15/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf

LUNESTA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 208451 AUROBINDO PHARMA LTD
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091024 DR REDDYS LABS LTD
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091166 GLENMARK GENERICS
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091124 LUPIN LTD
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 202929 MACLEODS PHARMS LTD
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091151 MYLAN PHARMS INC
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091113 ORCHID HLTHCARE
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091103 SUN PHARMA GLOBAL
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091169 TEVA
ESZOPICLONE ESZOPICLONE 1MG TABLET;ORAL Prescription No AB 091153 WEST-WARD PHARMS INT
LUNESTA ESZOPICLONE 1MG TABLET;ORAL Prescription Yes AB 021476 SUNOVION PHARMS INC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 208451 AUROBINDO PHARMA LTD
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091024 DR REDDYS LABS LTD
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091166 GLENMARK GENERICS
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091124 LUPIN LTD
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 202929 MACLEODS PHARMS LTD
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091151 MYLAN PHARMS INC
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091113 ORCHID HLTHCARE
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091103 SUN PHARMA GLOBAL
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091169 TEVA
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091153 WEST-WARD PHARMS INT
LUNESTA ESZOPICLONE 2MG TABLET;ORAL Prescription Yes AB 021476 SUNOVION PHARMS INC

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 208451 AUROBINDO PHARMA LTD
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091024 DR REDDYS LABS LTD
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091166 GLENMARK GENERICS
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091124 LUPIN LTD
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 202929 MACLEODS PHARMS LTD
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091151 MYLAN PHARMS INC
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091113 ORCHID HLTHCARE
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091103 SUN PHARMA GLOBAL
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091169 TEVA
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091153 WEST-WARD PHARMS INT
LUNESTA ESZOPICLONE 3MG TABLET;ORAL Prescription Yes AB 021476 SUNOVION PHARMS INC

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