Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076475
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/07647ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-19 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 06/20/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2014 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/31/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |