Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209397
Company: BEIJING
Company: BEIJING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 80MG BASE | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
04/26/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUVASTATIN SODIUM
TABLET, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209397 | BEIJING |
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079011 | TEVA PHARMS USA |
LESCOL XL | FLUVASTATIN SODIUM | EQ 80MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021192 | SANDOZ |