Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062338
Company: WARNER CHILCOTT LLC
Company: WARNER CHILCOTT LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYC | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 05/22/1981 | 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 |
|---|---|---|---|---|---|
| 12/21/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/06/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |