FDA Orange Book · active-ingredient family
Dimenhydrinate
Dimenhydrinate: 0 brands, 9 generics; first approved Jun 23, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
9
Listed patents
0
Presentations
9
Generic (ANDA) products (9)
Abbreviated applications
- DIMENHYDRINATERSFRESENIUS KABI USAANDA 0405192004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Rx — - DIMENHYDRINATEBAXTER HLTHCAREANDA 084767—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - DIMENHYDRINATEWATSON LABSANDA 083531—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - DIMENHYDRINATERLDWATSON LABS TEVAANDA 080615—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - DIMENHYDRINATEWYETH AYERSTANDA 084316—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued — - DIMENHYDRINATEALRAANDA 080715—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG/4ML LIQUID ORAL Discontinued — - DIMENHYDRINATEHEATHERANDA 080841—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DIMENHYDRINATENEXGEN PHARMA INCANDA 085985—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DIMENHYDRINATERLDWATSON LABSANDA 085166—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued —
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
22 yr 6 mo ago
Most recent approval
22 yr 6 mo ago
All 9 applications were approved in 2004.
Brand (NDA) 00%
Generic (ANDA) 9100%
Dimenhydrinate: 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.
