FDA Orange Book · active-ingredient family
Doxylamine succinate
Doxylamine succinate is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:UNISOM · NDA 018066
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| UNISOMRLD | CHATTEM | NDA 018066 | — | Approved Prior to Jan 1, 1982 | |
| UNISOM | PFIZER | NDA 019440 | — | Feb 05, 1986 | |
| DECAPRYN×2 | SANOFI AVENTIS US | NDA 006412 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOXYLAMINE SUCCINATE | LNK | ANDA 040564 | — | Aug 27, 2004 | |
| DOXYLAMINE SUCCINATE | PERRIGO | ANDA 040167 | — | Sep 18, 1996 | |
| DOXYLAMINE SUCCINATE | COPLEY PHARM | ANDA 088900 | — | Feb 12, 1988 | |
| DOXY-SLEEP-AID | PAR PHARM | ANDA 070156 | — | Jul 02, 1987 | |
| DOXYLAMINE SUCCINATE | QUANTUM PHARMICS | ANDA 088603 | — | Aug 07, 1984 |
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.
Doxylamine succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
