Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076337
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLAFEM 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 11/12/2010 | 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 |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/16/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/04/2014 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-6 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/28/2014 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |