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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 | Bayer AG |
Germany |
BAYER AG | 8539 | ACARBOSE | 1990-04-23 | Active | II | N/A | ||
| 28/03/2025 | CKD Bio Corporation |
South Korea |
CKD BIO CORP | 20759 | ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE | 2007-07-31 | Active | II | Complete | 2013-03-15 | 2013-02-26 |
