Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090479
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG | TABLET;ORAL-28 | Discontinued | None | No | No |
| NORGESTIMATE; ETHINYL ESTRADIOL | NORGESTIMATE; ETHINYL ESTRADIOL | 0.215MG; 0.025MG | TABLET; ORAL | Prescription | None | No | No |
| NORGESTIMATE; ETHINYL ESTRADIOL | NORGESTIMATE; ETHINYL ESTRADIOL | 0.25MG; 0.025MG | TABLET; ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 03/09/2011 | 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-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/03/2022 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |