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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Acebright India Pharma Private Limited |
India |
CDYMAX INDIA PHARMA PRIVATE LTD | 33226 | ERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) | 2018-09-29 | Active | II | N/A | ||
28/10/2024 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 30392 | ERLOTINIB HYDROCHLORIDE | 2016-03-30 | Active | II | Complete | 2016-04-27 | 2016-03-22 |
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