Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.
| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/10/2024 | Amino Chemicals |
Malta |
AMINO CHEMICALS LTD | 16785 | ZALEPLON | 2003-08-20 | Inactive | II | N/A | ||
| 28/10/2024 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INC | 22572 | ZALEPLON | 2009-02-25 | Inactive | II | N/A |
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