Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072697
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENCEPT 10/11-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,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 |
|---|---|---|---|---|---|---|---|
| 02/28/1992 | 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-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |