Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076675
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMOQUETTE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | 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 |
---|---|---|---|---|---|---|---|
02/25/2011 | 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-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/17/2022 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/26/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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04/13/2015 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/27/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |