Drugs@FDA: FDA-Approved Drugs
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-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
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 | 077322 | SANDOZ |
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 | 077322 | SANDOZ |
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 |