Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005490
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYNORAL | ETHINYL ESTRADIOL | 0.05MG | TABLET;ORAL | Discontinued | None | No | No |
| LYNORAL | ETHINYL ESTRADIOL | 0.01MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/13/1944 | ORIG-1 | Approval | UNKNOWN |
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