Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062200
Company: ALPHARMA US PHARMS
Company: ALPHARMA US PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | SUSPENSION;ORAL | Discontinued | None | No | No |
| ERYTHROMYCIN ETHYLSUCCINATE | 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 |
|---|---|---|---|---|---|---|---|
| 08/11/1981 | 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 |
|---|---|---|---|---|---|
| 12/23/2002 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 09/25/2000 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/26/1999 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1998 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 04/25/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/07/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 01/31/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 04/06/1992 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1991 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/26/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/22/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/07/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |