Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062468
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| C-SOLVE-2 | ERYTHROMYCIN | 2% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 07/03/1985 | 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 |
|---|---|---|---|---|---|
| 07/11/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/16/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/10/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/27/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |