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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205410
Company: PIERRE FABRE DERMA

Medication Guide

Products on NDA 205410

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEMANGEOL	PROPRANOLOL HYDROCHLORIDE	4.28MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205410

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205410Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205410Orig1s006ltr.pdf
04/02/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205410s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205410Orig1s005ltr.pdf
12/18/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205410s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205410Orig1s003ltr.pdf
05/18/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205410

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2021	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf
06/22/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf
04/02/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205410s005lbl.pdf
12/18/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205410s003lbl.pdf
03/14/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205410s000lbl.pdf

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