Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090374
Company: ORCHID HLTHCARE
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
09/17/2009 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
03/11/2014 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English