Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074911
Company: VALEANT
Company: VALEANT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHRENILIN WITH CAFFEINE AND CODEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/22/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74911ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/30/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/05/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |