Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090643
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUTILIDE FUMARATE | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
01/11/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090643s000ltr.pdf |
IBUTILIDE FUMARATE
INJECTABLE;INJECTION; 0.1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CORVERT | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020491 | PFIZER |
IBUTILIDE FUMARATE | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204146 | AVET LIFESCIENCES |
IBUTILIDE FUMARATE | IBUTILIDE FUMARATE | 0.1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090643 | MYLAN INSTITUTIONAL |