Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062999
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| E-BASE | ERYTHROMYCIN | 500MG | TABLET, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 11/25/1988 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/21/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |