Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078407
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 20MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 40MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/12/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/25/2020 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
06/05/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
12/31/2012 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
FLUVASTATIN SODIUM
CAPSULE;ORAL; EQ 20MG 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 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090595 | MYLAN PHARMS INC |
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078407 | TEVA PHARMS |
CAPSULE;ORAL; EQ 40MG 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 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090595 | MYLAN PHARMS INC |
FLUVASTATIN SODIUM | FLUVASTATIN SODIUM | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078407 | TEVA PHARMS |