Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091671
Company: NEOS THERAPS INC
Company: NEOS THERAPS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX | CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX | EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | SUSPENSION, 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 |
---|---|---|---|---|---|---|---|
06/29/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |