Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 2MG | TABLET;ORAL | Discontinued | None | No | No |
ESTRADIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/14/1996 | 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 |
---|---|---|---|---|---|
02/16/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2019 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/15/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/15/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/17/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/05/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/30/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/20/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/01/2000 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/13/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/10/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/20/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |