Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090468
Company: CYPRESS PHARM INC
Company: CYPRESS PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYFREL | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG/15ML;7.5MG/15ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 04/14/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090468Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |