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 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 38693 | VARENICLINE TARTRATE | 2023-08-30 | Active | II | N/A | ||
| 28/10/2024 | Actavis Inc |
Ireland |
ACTAVIS GROUP PTC EHF | 23791 | VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)] | 2010-05-06 | Active | II | N/A |
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