Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216848
Company: LEPU PHARM
Company: LEPU PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Discontinued | None | No | No |
ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
11/03/2022 | ORIG-1 | Approval | STANDARD |
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