Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021594
Company: INTL MEDICATION SYS
Company: INTL MEDICATION SYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
02/04/2004 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21594ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-594_Amiodarone.cfm |