Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208943
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
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 |
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 |
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 |
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 | ENDO OPERATIONS |
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 | 219050 | CAPLIN |
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 |