Doxepin Oral Tablet

Brand(s)
Silenor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pernix Therapeutics, Llc (2014-10-27)
Oldest Current Product
2010-08-01
License(s)
NDA
RxNORM
ORAL TABLET\DOXEPIN
FDAOB
ORAL\TABLET\DOXEPIN HYDROCHLORIDE
SPL Active
ORAL\TABLET\DOXEPIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\DOXEPIN

product(s) by strength(s)

doxepin 3 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428470103SilenorNDAPernix Therapeutics, Llc2010-08-01DOXEPIN HYDROCHLORIDEORALTABLETNDA0220361bec1223-5239-4eb6-a9e8-62444106d2c0

doxepin 6 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1428470106SilenorNDAPernix Therapeutics, Llc2010-08-01DOXEPIN HYDROCHLORIDEORALTABLETNDA0220361bec1223-5239-4eb6-a9e8-62444106d2c0

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA201951DOXEPIN HYDROCHLORIDEACTAVIS ELIZABETH LLC2013-07-26ANDA201951_001, ANDA201951_002
2NDA022036SILENORPERNIX THERAPEUTICS LLC2010-03-17p6211229, TREATMENT OF INSOMNIA
p9107898, TREATMENT OF INSOMNIA, SUBSTANCE
p8513299, TREATMENT OF INSOMNIA
p6217909, SUBSTANCE
p5585115, SUBSTANCE
p5948438, SUBSTANCE
p5725884, SUBSTANCE
p5866166, SUBSTANCE
p6103219, SUBSTANCE
p7915307, TREATMENT OF INSOMNIA
NDA022036_001, NDA022036_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201951_001RXDOXEPIN HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2013-07-26DOXEPIN HYDROCHLORIDE
2ANDA201951_002RXDOXEPIN HYDROCHLORIDE (EQ 6MG BASE)ORALTABLETFalseAB2013-07-26DOXEPIN HYDROCHLORIDE
3NDA022036_001RXDOXEPIN HYDROCHLORIDE (EQ 3MG BASE)ORALTABLETFalseAB2010-03-17SILENOR
4NDA022036_002RXDOXEPIN HYDROCHLORIDE (EQ 6MG BASE)ORALTABLETTrueAB2010-03-17SILENOR

patent(s)

#idexpiration dateapplication(s)
1p5585115 (view patent)2015-01-09NDA022036
2p5725884 (view patent)2015-01-09NDA022036
3p5866166 (view patent)2015-01-09NDA022036
4p5948438 (view patent)2015-01-09NDA022036
5p6103219 (view patent)2015-01-09NDA022036
6p6211229 (view patent)2020-02-17NDA022036
7p6217909 (view patent)2015-01-09NDA022036
8p7915307 (view patent)2027-08-24NDA022036
9p8513299 (view patent)2030-04-14NDA022036
10p9107898 (view patent)2028-05-01NDA022036

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11bec1223-5239-4eb6-a9e8-62444106d2c0 (view SPL)These highlights do not include all the information needed to use Silenor safely and effectively. See full prescribing information for Silenor.Silenor (doxepin) tablets for oral administrationInitial U.S. Approval: 1969prescriptionHuman PrescriptionPernix Therapeutics, LlcAPI MANUFACTURE, MANUFACTURE, PACK2014-10-274428470103, 428470106

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII