Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG;0.5MG,1MG | TABLET;ORAL-28 | Prescription | 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 |
---|---|---|---|---|---|---|---|
04/01/1988 | 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-36 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-34 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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11/05/2002 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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11/05/2002 | SUPPL-12 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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06/26/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/21/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/10/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/31/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/08/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/01/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/04/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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08/10/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |