Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077239
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription AB No No
ZALEPLON ZALEPLON 10MG CAPSULE;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
06/06/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077239s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077239s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2015 SUPPL-1 Labeling-Medication Guide, 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
06/06/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077239s000lbl.pdf

ZALEPLON

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SONATA ZALEPLON 5MG CAPSULE;ORAL Prescription Yes AB 020859 PFIZER
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078829 AUROBINDO PHARMA
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077505 CIPLA LTD
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078147 HIKMA PHARMS
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 090374 ORCHID HLTHCARE
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077239 TEVA PHARMS
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 078989 UNICHEM
ZALEPLON ZALEPLON 5MG CAPSULE;ORAL Prescription No AB 077237 WEST-WARD PHARMS INT

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SONATA ZALEPLON 10MG CAPSULE;ORAL Prescription Yes AB 020859 PFIZER
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078829 AUROBINDO PHARMA
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077505 CIPLA LTD
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078147 HIKMA PHARMS
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 090374 ORCHID HLTHCARE
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077239 TEVA PHARMS
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 078989 UNICHEM
ZALEPLON ZALEPLON 10MG CAPSULE;ORAL Prescription No AB 077237 WEST-WARD PHARMS INT

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