Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212806
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/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 |
---|---|---|---|---|---|---|---|
04/11/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
REGADENOSON
SOLUTION;INTRAVENOUS; 0.4MG/5ML (0.08MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LEXISCAN | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022161 | ASTELLAS |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213236 | ACCORD HLTHCARE |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207604 | APOTEX |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 217455 | BAXTER HLTHCARE CORP |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213210 | DR REDDYS |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216437 | EUGIA PHARMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215955 | GE HEALTHCARE |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 207320 | GLAND PHARMA LTD |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215827 | HIKMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214349 | HOSPIRA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214252 | IMS LTD |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218054 | INDIES PHARMA |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212806 | MEITHEAL |
REGADENOSON | REGADENOSON | 0.4MG/5ML (0.08MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213856 | MYLAN |