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): 078148
Company: ANCHEN PHARMS
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
12/03/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078148s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/19/2019 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/19/2019 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/19/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/19/2019 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/19/2015 SUPPL-9 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/01/2014 SUPPL-7 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 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 213592 BRECKENRIDGE
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 PHARM

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 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 213592 BRECKENRIDGE
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 PHARM
Back to Top