Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040135
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTROPIPATE | ESTROPIPATE | 0.75MG | TABLET;ORAL | Discontinued | None | No | No |
ESTROPIPATE | ESTROPIPATE | 1.5MG | TABLET;ORAL | Discontinued | None | No | No |
ESTROPIPATE | ESTROPIPATE | 3MG | 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 |
---|---|---|---|---|---|---|---|
11/27/1996 | 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 |
---|---|---|---|---|---|
04/03/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/23/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/21/1999 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/06/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/20/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/09/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |