Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208276
Company: UNITED THERAP

Products on NDA 208276

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REMODULIN	TREPROSTINIL	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
REMODULIN	TREPROSTINIL	50MG/20ML (2.5MG/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
REMODULIN	TREPROSTINIL	100MG/20ML (5MG/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
REMODULIN	TREPROSTINIL	200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208276Orig1s000TOC.cfm

Labels for NDA 208276

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf