FDA Orange Book · active-ingredient family
Dextromethorphan polistirex
Dextromethorphan polistirex: 1 brand, 3 generics; first approved Oct 08, 1982; generic available.
Generic available
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- RECKITT BENCKISERNDA 0186581982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE ORAL OTC —
Generic (ANDA) products (3)
Abbreviated applications
- DEXTROMETHORPHAN POLISTIREXAUROBINDO PHARMA LTDANDA 2184172026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE ORAL OTC — - DEXTROMETHORPHAN POLISTIREXAMNEALANDA 2031332017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE ORAL OTC — - DEXTROMETHORPHAN POLISTIREXTRIS PHARMA INCANDA 0911352012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG HYDROBROMIDE/5ML SUSPENSION, EXTENDED RELEASE ORAL OTC —
Listed patents
Orange Book patent file
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
FDA approval span
First approval
44 yr 6 mo ago
Most recent approval
4 mo ago
Approvals span 1982–2026 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Dextromethorphan 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
