Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073479
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 300MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1992 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073479_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/12/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/27/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/01/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |