Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077273
Company: ECR PHARMA
Company: ECR PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TUSSICAPS | CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | EQ 8MG MALEATE;EQ 10MG BITARTRATE | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TUSSICAPS | CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | EQ 4MG MALEATE;EQ 5MG BITARTRATE | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 09/24/2007 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077273s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077273s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/20/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/24/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077273s000lbl.pdf |