Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205904
Company: LUPIN
Company: LUPIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DRONEDARONE HYDROCHLORIDE | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
01/31/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205904Orig1s000ltr.pdf |
DRONEDARONE HYDROCHLORIDE
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DRONEDARONE HYDROCHLORIDE | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 205904 | LUPIN |
MULTAQ | DRONEDARONE HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022425 | SANOFI AVENTIS US |