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FDA NDA · NDA209321

RUZURGI

Sponsor: JACOBUS PHARM CO INC

APPLICATION
NDA209321
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

RUZURGI · ReferenceNone (Tentative Approval)
AMIFAMPRIDINE 10MG · TABLET · ORAL

Approval history

2022-02-01Type 2 - New Active Ingredient · Original · priorityLetterTA
2022-02-01Labeling · Supplement 1 · standardTA
2019-05-06Efficacy · Original · priorityLetterTA
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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