Requests that the FDA to allow us to add the 100 mL bottle in ANDA 214382, according to the FDA guidance document "Determining Whether to Submit an ANDA or a 505(b) (2) Application", effective May 2019.
🏛 Food and Drug Administration (FDA)FDA-2026-P-3840
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Rules, notices, and supporting material — the primary rule pinned first.
- Other· Jul 6, 2026No comment period
- Other· Apr 10, 2026Suitability Petition from Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd→No comment period