Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076828
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL LACTATE | EQ 5MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 08/25/2004 | 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 |
|---|---|---|---|---|---|
| 10/19/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/31/2007 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076791s004,076828s003ltr.pdf |