Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021476
Company: WAYLIS THERAP
Company: WAYLIS THERAP
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 |
---|---|---|---|---|---|
08/18/2019 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf | |
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 |
---|---|---|---|---|---|
08/18/2019 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf | |
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 |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 091024 | DR REDDYS |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 091166 | GLENMARK PHARMS LTD |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 205504 | HETERO LABS LTD V |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 206222 | IPCA LABS LTD |
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 | ORBION PHARMS |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 091103 | SUN PHARM |
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | No | AB | 091169 | TEVA |
LUNESTA | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 021476 | WAYLIS THERAP |
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 |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 091024 | DR REDDYS |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 091166 | GLENMARK PHARMS LTD |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 205504 | HETERO LABS LTD V |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 206222 | IPCA LABS LTD |
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 | ORBION PHARMS |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 091103 | SUN PHARM |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | No | AB | 091169 | TEVA |
LUNESTA | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 021476 | WAYLIS THERAP |
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 |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 091024 | DR REDDYS |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 091166 | GLENMARK PHARMS LTD |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 205504 | HETERO LABS LTD V |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 206222 | IPCA LABS LTD |
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 | ORBION PHARMS |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 091103 | SUN PHARM |
ESZOPICLONE | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | No | AB | 091169 | TEVA |
LUNESTA | ESZOPICLONE | 3MG | TABLET;ORAL | Prescription | Yes | AB | 021476 | WAYLIS THERAP |