Drugs@FDA: FDA-Approved Drugs
Company: WATSON PHARMS TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHIN 1/35E-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | 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 |
---|---|---|---|---|---|---|---|
04/12/1988 | 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-13 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/09/2017 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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07/11/1997 | SUPPL-11 | Labeling |
Label is not available on this site. |
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12/23/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/28/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
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10/11/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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10/11/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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09/09/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/19/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |