Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062304
Company: ARBOR PHARMS LLC
Company: ARBOR PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDIAMYCIN | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| PEDIAMYCIN 400 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | 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 |
|---|---|---|---|---|---|---|---|
| 12/18/1980 | 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 |
|---|---|---|---|---|---|
| 04/28/2016 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2006 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/07/2004 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 10/02/2001 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 03/13/2001 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/29/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/16/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 12/09/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |