FDA Orange Book · active-ingredient family
Dimenhydrinate
Dimenhydrinate is approved in 9 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIMENHYDRINATE | FRESENIUS KABI USA | ANDA 040519 | — | Jun 23, 2004 | |
| DIMENHYDRINATE | BAXTER HLTHCARE | ANDA 084767 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATE | WATSON LABS | ANDA 083531 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATERLD | WATSON LABS TEVA | ANDA 080615 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATE | WYETH AYERST | ANDA 084316 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATE | ALRA | ANDA 080715 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATE | HEATHER | ANDA 080841 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATE | NEXGEN PHARMA INC | ANDA 085985 | — | Approved Prior to Jan 1, 1982 | |
| DIMENHYDRINATERLD | WATSON LABS | ANDA 085166 | — | Approved Prior to Jan 1, 1982 |
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.
Dimenhydrinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
