Dextromethorphan hydrobromide; promethazine hydrochloride
Dextromethorphan hydrobromide; promethazine hydrochloride: 1 brand, 9 generics; first approved Apr 02, 1984; generic available.
Generic available: 9 ANDA applications approved.
Brand (NDA) products
- ANI PHARMSNDA 0112651984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA
Generic (ANDA) products (9)
- RUBICON RESEARCHANDA 2208692026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - HETERO LABS LTD IIIANDA 2182642026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - COSETTE PHARMS NCANDA 0916872012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - AMNEAL PHARMSANDA 0905752011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - PAI HOLDINGSANDA 0406492006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - HIKMAANDA 0400271996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Discontinued — - HALSEYANDA 0889131987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Discontinued — - PHARMOBEDIENTANDA 0888641985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Rx AA - G AND W LABS INCANDA 0887621984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG/5ML;6.25MG/5ML SYRUP ORAL Discontinued —
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 1984–2026 across 10 FDA applications.
Dextromethorphan hydrobromide; promethazine hydrochloride: 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.
