Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061461
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ERYTHROMYCIN STEARATE | ERYTHROMYCIN STEARATE | EQ 500MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/11/1980 | 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 |
|---|---|---|---|---|---|
| 08/20/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 05/14/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 03/23/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/23/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |