Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063107
Company: ALTANA
Company: ALTANA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMGEL | ERYTHROMYCIN | 2% | GEL;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/23/1991 | 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 |
|---|---|---|---|---|---|
| 04/04/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |