Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072622
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | 20% | SOLUTION;INHALATION, 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1992 | 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 |
|---|---|---|---|---|---|
| 08/28/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/25/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |