Drugs@FDA: FDA-Approved Drugs
Company: ARBOR PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE | TABLET;ORAL | Discontinued | None | No | No |
E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE | TABLET;ORAL | Prescription | BX | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/12/1982 | 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 |
---|---|---|---|---|---|
09/01/2015 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
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10/31/2013 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf | |
02/25/2009 | SUPPL-45 | Labeling |
Label is not available on this site. |
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02/25/2009 | SUPPL-44 | Labeling |
Label is not available on this site. |
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07/21/2006 | SUPPL-43 | Labeling |
Label is not available on this site. |
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12/09/2002 | SUPPL-40 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/09/2002 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/03/2003 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/17/2001 | SUPPL-37 | Labeling |
Label is not available on this site. |
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04/20/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/2000 | SUPPL-35 | Labeling |
Label is not available on this site. |
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07/29/1994 | SUPPL-34 | Labeling |
Label is not available on this site. |
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07/29/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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08/18/1992 | SUPPL-32 | Labeling |
Label is not available on this site. |
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08/18/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/31/2013 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf |
E.E.S. 400
There are no Therapeutic Equivalents.