Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071364
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETYLCYSTEINE | ACETYLCYSTEINE | 10% | 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 |
|---|---|---|---|---|---|---|---|
| 11/20/2007 | 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 |
|---|---|---|---|---|---|
| 08/29/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/18/2002 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/04/2001 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/10/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |