Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061639
Company: ARBOR PHARMS LLC
Company: ARBOR PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
E.E.S. 200 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |
E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
10/15/1973 | 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-33 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf | |
02/25/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
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02/25/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
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07/21/2006 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
01/17/2001 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/16/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
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11/28/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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09/26/1991 | SUPPL-19 | 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-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf |