Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077214
Company: ACME LABS
Company: ACME LABS
| 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/2007/077214s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/01/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-1 | 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 |
| 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 |
| 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 |