Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076470
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE | 0.2MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076470ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/02/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |