U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077884
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription AB No No
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG 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
04/23/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077884s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2022 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

10/25/2019 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/25/2019 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/25/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

10/25/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/25/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/13/2014 SUPPL-13 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/04/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/21/2009 SUPPL-9 Labeling

Label is not available on this site.

05/29/2008 SUPPL-5 Labeling

Label is not available on this site.

ZOLPIDEM TARTRATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription Yes AB 019908 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077214 ACME LABS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077884 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078413 AUROBINDO PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077388 CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 078184 INVAGEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077322 SANDOZ INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 076410 TEVA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 5MG TABLET;ORAL Prescription No AB 077903 TORRENT PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription Yes AB 019908 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077214 ACME LABS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077884 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078413 AUROBINDO PHARMA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077388 CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 078184 INVAGEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077322 SANDOZ INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 076410 TEVA
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 10MG TABLET;ORAL Prescription No AB 077903 TORRENT PHARMS
Back to Top