Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211281
Company: BRAINTREE LABS

Products on NDA 211281

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211281

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

Labels for NDA 211281

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

Therapeutic Equivalents for NDA 211281

PIZENSY

There are no Therapeutic Equivalents.