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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211281
Company: BRAINTREE LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIZENSY LACTITOL 10GM FOR SOLUTION;ORAL Discontinued None Yes No
PIZENSY LACTITOL 20G SOLUTION;ORAL Prescription TBD TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/12/2020 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211281Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211281Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2021 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211281s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211281Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/17/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211281s001lbl.pdf
02/12/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf

PIZENSY

There are no Therapeutic Equivalents.

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