Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062353
Company: ALPHARMA US PHARMS
Company: ALPHARMA US PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN ESTOLATE | ERYTHROMYCIN ESTOLATE | EQ 125MG 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1982 | 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 |
|---|---|---|---|---|---|
| 01/18/2001 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/11/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/09/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/27/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |