Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019616
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENETREX | ENOXACIN | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| PENETREX | ENOXACIN | 400MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/31/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf |
| 08/21/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf |
| 08/21/2002 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf |
| 06/03/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/10/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |