Drugs@FDA: FDA-Approved Drugs
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL | ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL | EQ 200MG BASE/5ML;EQ 600MG BASE/5ML | GRANULE;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 |
|---|---|---|---|---|---|---|---|
| 05/20/1988 | 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 |
|---|---|---|---|---|---|
| 12/16/2015 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/20/1999 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/28/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 11/08/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/01/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 10/30/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/08/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/08/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |