Application 019908
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMBIEN | ZOLPIDEM TARTRATE | TABLET;ORAL | 5MG | Yes | No |
| 002 | AMBIEN | ZOLPIDEM TARTRATE | TABLET;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0024-5401 | Ambien | zolpidem tartrate | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5401 | Ambien | zolpidem tartrate | sanofi-aventis U.S. LLC | NDA | Current |
| 0024-5401 | Ambien | zolpidem tartrate | sanofi-aventis U.S. LLC | NDA | Current |
| 0024-5401 | Ambien | zolpidem tartrate | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5421 | Ambien | zolpidem tartrate | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0024-5421 | Ambien | zolpidem tartrate | sanofi-aventis U.S. LLC | NDA | Current |
| 0024-5421 | Ambien | zolpidem tartrate | sanofi-aventis U.S. LLC | NDA | Current |
| 0024-5421 | Ambien | zolpidem tartrate | Sanofi-Aventis U.S. LLC | NDA | Current |
| 21695-211 | Ambien | zolpidem tartrate | Rebel Distributors Corp. | NDA | Current |
| 21695-212 | Ambien | zolpidem tartrate | Rebel Distributors Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70267 | SUPPL | 2022-02-25 |
| 70266 | SUPPL | 2022-02-25 |
| 70265 | SUPPL | 2022-02-25 |
| 70264 | SUPPL | 2022-02-25 |
| 70245 | SUPPL | 2022-02-24 |
| 70244 | SUPPL | 2022-02-24 |
| 70243 | SUPPL | 2022-02-24 |
| 59776 | SUPPL | 2019-08-20 |
| 59775 | SUPPL | 2019-08-20 |
| 59758 | SUPPL | 2019-08-20 |
| 57598 | SUPPL | 2019-02-14 |
| 57480 | SUPPL | 2019-02-07 |
| 57400 | SUPPL | 2019-02-01 |
| 55739 | SUPPL | 2018-10-01 |
| 55601 | SUPPL | 2018-09-24 |
| 55512 | SUPPL | 2018-09-18 |
| 55500 | SUPPL | 2018-09-18 |
| 48861 | SUPPL | 2017-06-29 |
| 47500 | SUPPL | 2017-03-08 |
| 47473 | SUPPL | 2017-03-06 |
| 46051 | SUPPL | 2016-12-06 |
| 46022 | SUPPL | 2016-12-05 |
| 45043 | SUPPL | 2016-08-24 |
| 45042 | SUPPL | 2016-08-24 |
| 34090 | SUPPL | 2014-10-09 |
| 19833 | SUPPL | 2014-10-09 |
| 20421 | SUPPL | 2013-09-30 |
| 20420 | SUPPL | 2013-09-30 |
| 19832 | SUPPL | 2013-04-24 |
| 19831 | SUPPL | 2013-04-24 |
| 34089 | SUPPL | 2013-04-23 |
| 11841 | SUPPL | 2013-04-23 |
| 34088 | SUPPL | 2010-04-19 |
| 19830 | SUPPL | 2010-04-19 |
| 11840 | SUPPL | 2008-05-28 |
| 1802 | SUPPL | 2008-05-09 |
| 1801 | SUPPL | 2007-10-22 |
| 41092 | SUPPL | 2007-07-09 |
| 19829 | SUPPL | 2007-04-09 |
| 11839 | SUPPL | 2007-03-31 |
| 23560 | ORIG | 2007-03-16 |
| 20419 | ORIG | 2005-07-13 |
| 66832 | SUPPL | 1900-01-01 |
| 52156 | SUPPL | 1900-01-01 |
| 52155 | SUPPL | 1900-01-01 |
| 52154 | SUPPL | 1900-01-01 |