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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/07/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 34971 | DEXLANSOPRAZOLE | 2020-09-29 | Active | II | N/A | ||
| 29/07/2025 | Lee Pharma |
India |
LEE PHARMA LTD | 38183 | DEXLANSOPRAZOLE SESQUIHYDRATE | 2023-04-03 | Active | II | N/A |
