Orange Book product · Brand (NDA)
UNISOM
DOXYLAMINE SUCCINATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DOXYLAMINE SUCCINATE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018066
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1986UNISOMBrand (NDA)
NDA 019440 · PFIZER
- —DECAPRYNBrand (NDA)
NDA 006412 · SANOFI AVENTIS US
- 2004DOXYLAMINE SUCCINATEGeneric (ANDA)
ANDA 040564 · LNK
- 1996DOXYLAMINE SUCCINATEGeneric (ANDA)
ANDA 040167 · PERRIGO
- 1988DOXYLAMINE SUCCINATEGeneric (ANDA)
ANDA 088900 · COPLEY PHARM
- 1987DOXY-SLEEP-AIDGeneric (ANDA)
ANDA 070156 · PAR PHARM
- 1984DOXYLAMINE SUCCINATEGeneric (ANDA)
ANDA 088603 · QUANTUM PHARMICS
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.
