Drugs@FDA: FDA-Approved Drugs
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/08/1972 | 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 |
---|---|---|---|---|---|
05/29/2014 | SUPPL-23 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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12/23/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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05/01/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |