Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN ESTOLATE | ERYTHROMYCIN ESTOLATE | EQ 125MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
ERYTHROMYCIN ESTOLATE | ERYTHROMYCIN ESTOLATE | EQ 250MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/15/1981 | 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 |
---|---|---|---|---|---|
12/21/1999 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/27/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
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05/20/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
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12/23/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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10/28/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/08/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |