Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077075
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GILDESS 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Discontinued | None | No | No |
GILDESS FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | 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 |
---|---|---|---|---|---|---|---|
04/28/2005 | 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 |
---|---|---|---|---|---|
04/30/2014 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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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. |