Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062162
Company: BARR
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. |
||
| 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. |