Chlorpheniramine polistirex; hydrocodone polistirex
Chlorpheniramine polistirex; hydrocodone polistirex: 1 brand, 3 generics; first approved Dec 31, 1987; generic available.
Generic available — 3 ANDA applications approved.
Brand (NDA) products
UCB INCNDA 0191111987
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION, EXTENDED RELEASE | ORAL | Discontinued | — |
Generic (ANDA) products (3)
NEOS THERAPS INCANDA 0916712012
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | SUSPENSION, EXTENDED RELEASE | ORAL | Discontinued | — |
TRIS PHARMA INCANDA 0916322010
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML | SUSPENSION, EXTENDED RELEASE | ORAL | Rx | — |
ECR PHARMAANDA 07727320072 strengths
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 8MG MALEATE;EQ 10MG BITARTRATE | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
| EQ 4MG MALEATE;EQ 5MG BITARTRATE | CAPSULE, EXTENDED RELEASE | ORAL | Discontinued | — |
Listed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1987–2012 across 4 FDA applications.
Chlorpheniramine polistirex; hydrocodone polistirex — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
