Orange Book product · Brand (NDA)
SINEQUAN
DOXEPIN HYDROCHLORIDE
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
DOXEPIN HYDROCHLORIDE
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016798
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —DOXEPIN HYDROCHLORIDEBrand (NDA)
NDA 016987 · NEW RIVER
- 2023DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217975 · UNIQUE
- 2023DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217688 · MICRO LABS
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215113 · MSN
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 213796 · ADAPTIS
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215483 · JUBILANT CADISTA
- 2022DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215710 · MANKIND PHARMA
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 215076 · ALEMBIC
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 214908 · APPCO
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211619 · IXORA LIFESCIENCE
- 2021DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211618 · VELZEN PHARMA PVT
- 2020DOXEPIN HYDROCHLORIDEGeneric (ANDA)
ANDA 210675 · EPIC PHARMA LLC
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.
