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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 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 39002 | BENZONATATE | 2023-12-04 | Active | II | N/A | ||
| 28/03/2025 | Catalent Pharma Solutions |
U.S.A |
CATALENT PHARMA SOLUTIONS LLC | 12327 | TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES | 1997-01-21 | Inactive | II | N/A |
