Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORTHO-EST | ESTROPIPATE | 0.75MG | 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 |
---|---|---|---|---|---|---|---|
02/27/1991 | 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-21 | Labeling-Package Insert |
Label is not available on this site. |
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07/21/2004 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/07/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
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06/11/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
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03/19/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/19/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/12/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/22/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/23/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/21/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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04/19/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |