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doi: 10.3969/j.issn.1672-5123.2010.06.034 9

Stage 4: Dosage Form and Strength Expansion (Years 8-18 from NDA) sNDAs for new dosage forms (e.g., tablet to capsule, immediate-release to extended-release, oral to patch), new strengths, or new routes of administration each earn 3-year NCS exclusivity if supported by new clinical investigations

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