Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078179
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;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
06/06/2011 ORIG-2 Approval

Label is not available on this site.

10/13/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078179s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

ZOLPIDEM TARTRATE

TABLET, EXTENDED RELEASE;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN CR ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021774 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078179 ACTAVIS ELIZABETH
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078970 LUPIN LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090107 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 12.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204170 SUN PHARMA GLOBAL

TABLET, EXTENDED RELEASE;ORAL; 6.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBIEN CR ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021774 SANOFI AVENTIS US
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078179 ACTAVIS ELIZABETH
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090153 ACTAVIS LABS FL INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078148 ANCHEN PHARMS
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200266 APOTEX INC
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078970 LUPIN LTD
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090107 SANDOZ
ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE 6.25MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204170 SUN PHARMA GLOBAL

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