Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073592
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVORA 0.15/30-21 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-21 | 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 |
---|---|---|---|---|---|---|---|
12/13/1993 | 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-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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03/09/2022 | SUPPL-21 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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08/16/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/31/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/10/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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06/10/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |