Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075220
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.004MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 08/28/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75220ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/04/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/23/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/24/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/20/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/06/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |