Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201897
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2016 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/27/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/27/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2022 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/09/2018 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/09/2018 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |