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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208587
Company: EMMAUS MEDCL

Products on NDA 208587

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENDARI	L-GLUTAMINE	5GM/PACKET	FOR SOLUTION;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208587

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2017	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/2017/208587s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208587Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208587Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s003ltr.pdf
04/22/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208587Orig1s002ltr.pdf
11/01/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208587s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208587Orig1s001ltr.pdf

Labels for NDA 208587

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s003lbl.pdf
04/22/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208587s002lbl.pdf
11/01/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208587s001lbl.pdf
07/07/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208587s000lbl.pdf

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