Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040458
Company: GENUS
Company: GENUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBINOXAMINE MALEATE | CARBINOXAMINE MALEATE | 4MG/5ML | SOLUTION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/25/2003 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040458_CarbinoxamineTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/25/2010 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/09/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/15/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |