Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208943
Company: PAR STERILE PRODUCTS

Products on NDA 208943

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORPHEDRA	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208943

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208943Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208943Orig1s000TOC.cfm

Labels for NDA 208943

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf

Therapeutic Equivalents for NDA 208943

CORPHEDRA

SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AKOVAZ	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	208289	EXELA PHARMA
CORPHEDRA	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208943	PAR STERILE PRODUCTS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212932	AMNEAL
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212649	DR REDDYS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214579	EUGIA PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209646	FRESENIUS KABI USA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216146	GLAND PHARMA LTD
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214334	HIKMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216129	MANKIND PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214528	SAGENT PHARMS INC
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209784	SANDOZ
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215825	XIROMED