Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076812
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL AND NORGESTIMATE | ESTRADIOL; NORGESTIMATE | 1MG,1MG;N/A,0.09MG | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/29/2005 | 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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/03/2017 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/26/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |