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FDA ANDA · ANDA209413

MIRABEGRON

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA209413
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

MIRABEGRONNone (Tentative Approval)
MIRABEGRON 50MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2018-10-12UNKNOWN · Original · standardLetterTA
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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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