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FDA NDA · NDA211281

PIZENSY

Sponsor: BRAINTREE LABS

APPLICATION
NDA211281
TYPE
NDA
ORIGINAL APPROVAL
2020-02-12
LATEST ACTION
2021-08-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION, FOR SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

PIZENSYPrescription
LACTITOL 20G · SOLUTION · ORAL
PIZENSY · ReferenceDiscontinued
LACTITOL 10GM · FOR SOLUTION · ORAL

Approval history

2021-08-17Labeling · Supplement 1 · standard — Letter ↗AP
2020-02-12Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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