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| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 14036 | NIZATIDINE USP | 1999-03-16 | Active | II | Complete | 2013-09-04 | 2013-08-23 |
| 28/03/2025 | Eli Lilly |
U.S.A |
ELI LILLY AND CO | 6034 | BULK PRODUCTION OF NIZATIDINE | 1985-09-23 | Inactive | II | N/A |
