Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076501
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADENOSINE | ADENOSINE | 3MG/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 |
|---|---|---|---|---|---|---|---|
| 06/16/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76501ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076501.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/24/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |