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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Ami Lifesciences Private Limited |
India |
AMI LIFESCIENCES PRIVATE LTD | 40078 | DICYCLOMINE HYDROCHLORIDE | 2024-09-21 | Active | II | N/A | ||
| 31/10/2025 | Honour Lab Limited |
India |
HONOUR LAB LTD | 36977 | DICYCLOMINE HYDROCHLORIDE | 2022-04-04 | Active | II | Complete | 2022-05-10 | 2022-03-25 |
