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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 | Apicore |
India |
APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC) | 40970 | DEGARELIX ACETATE | 2024-12-28 | Active | II | N/A | ||
| 31/10/2025 | Apicore |
India |
APICORE LLC | 37113 | DEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE) | 2023-04-25 | Active | II | N/A |
