Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091169
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESZOPICLONE | ESZOPICLONE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
ESZOPICLONE | ESZOPICLONE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
ESZOPICLONE | ESZOPICLONE | 3MG | 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 |
---|---|---|---|---|---|---|---|
05/23/2011 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091169s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/07/2019 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/07/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/07/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/07/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/05/2014 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/22/2014 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
ESZOPICLONE
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 |