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Mycophenolate Mofetil capsules 250mg
Currently approved by the US FDA ANDA No.: 214079
Passed the FDA on-site inspection in September 2023. On May 21, 2024, the company received the PAI EIR report sent by the FDA in an encrypted format, which stated that the company has the conditions to apply for commercial production of the product. This is the third time the company has passed the FDA on-site inspection. The entire ANDA project was approved for marketing in early November 2024. |
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