Drugs@FDA: FDA-Approved Drugs
Company: PROMIUS PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SECTRAL | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
SECTRAL | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/28/1984 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/03/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018917s025ltr.pdf | |
09/06/2007 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018917s024_ltr.pdf | |
07/13/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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08/22/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
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11/07/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
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08/10/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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10/03/1988 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/05/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
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03/24/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1987 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/18/1987 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/20/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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12/05/1988 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/04/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
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06/11/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/25/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/09/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/28/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/06/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/03/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018917s025lbl.pdf | |
09/06/2007 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018917s024lbl.pdf |