Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006012
Company: LEDERLE
Company: LEDERLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOLVRON | FERROUS SULFATE; FOLIC ACID | 182MG;0.33MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
08/13/1946 | 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 |
---|---|---|---|---|---|
12/14/1981 | SUPPL-6 | Efficacy |
Label is not available on this site. |
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10/14/1980 | SUPPL-3 | Efficacy |
Label is not available on this site. |