Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077077
Company: VINTAGE PHARMS LLC
Company: VINTAGE PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GILDESS 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| GILDESS FE 1/20 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;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 |
|---|---|---|---|---|---|---|---|
| 05/20/2005 | 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 |
|---|---|---|---|---|---|
| 09/29/2016 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/28/2014 | SUPPL-7 | Labeling-Proprietary Name Change |
Label is not available on this site. |
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| 03/27/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |