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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091113
Company: ORBION PHARMS
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
06/10/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2020 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/27/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/27/2020 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

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 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 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 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
ESZOPICLONE ESZOPICLONE 2MG TABLET;ORAL Prescription No AB 091024 DR REDDYS
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 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 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
ESZOPICLONE ESZOPICLONE 3MG TABLET;ORAL Prescription No AB 091024 DR REDDYS
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 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 SUNOVION PHARMS INC
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