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Generated: June 27, 2019

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Temazepam - Generic Drug Details

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What are the generic drug sources for temazepam and what is the scope of temazepam freedom to operate?

Temazepam is the generic ingredient in three branded drugs marketed by Specgx Llc, Quantum Pharmics, Actavis Elizabeth, Alembic Pharms Ltd, Amneal Pharms, Duramed Pharms Barr, Mylan, Novel Labs Inc, Prinston Inc, Sandoz, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for temazepam. Thirty-seven suppliers are listed for this compound.

Pharmacology for temazepam
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for temazepam
Synonyms for temazepam
1-methyl-7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepine-2-one
1,3-Dihydro-7-chloro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
2H-1, 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 1,3-dihydro-7-chloro-3-hydroxy-1-methyl-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-
3-hydroxy-1,3-dihydro-1-methyl-7-chloro-5-phenyl-2H-1,4-benzodiazepin-2-one
3-Hydroxydiazepam
5-25-02-00242 (Beilstein Handbook Reference)
7-CHLORO-1,3-DIHYDRO-3-HYDROXY-1-METHYL-5-PHENYL-2H-1,4-BENZODIAZEPIN-2-ONE
7-Chloro-3-hydroxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
7-Chloro-3-hydroxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one #
7-chloro-3-hydroxy-1-methyl-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one
7-chloro-3-hydroxy-1-methyl-5-phenyl-3H-1,4-benzodiazepin-2-one
846-50-4
AB01563160_01
AC1L1K92
AN-20538
Apo-Temazepam
BDBM50408032
BRN 0759300
C07125
CAS-846-50-4
CCG-213642
CCRIS 1954
Cerepax
CHEBI:9435
CHEMBL967
Crisonar
D00370
Dasuen
DB00231
DEA No. 2925
Diazepam, 3-hydroxy
DivK1c_000989
DSSTox_CID_1309
DSSTox_GSID_21309
DSSTox_RID_76071
DTXSID8021309
EINECS 212-688-1
ER 115
Euhypnos
Euipnos
FT-0674841
Gelthix
GTPL7300
HMS503E19
Hydroxydiazepam
IDI1_000989
K-3917
K3917
KBio1_000989
Lenal
Levanxene
Levanxol
Levanzene
LS-7712
Mabertin
Methyloxazepam
MLS003899242
N-Methyloxazepam
NCGC00159440-02
NCGC00159440-03
NCGC00257598-01
Neodorm SP
NINDS_000989
Nocturne
Nomapam
Norkotral Tema
Normison
Normitab
Nortem
Novo-Temazepam
NSC 246303
NSC-246303
NSC246303
Oxydiazepam
Perdorm
Planum
Pronervon T
Remestan
Restoril
Restoril (TN)
Ro 5-5345
Ro-5-5345
Ro-5-5354
SaH 47-603
SCHEMBL29463
SEQDDYPDSLOBDC-UHFFFAOYSA-N
Signopam
SMR000238146
Strazepam
Temador
Temaz
temazep von ct
Temazepam (USP/INN)
Temazepam [USAN:INN:BAN]
Temazepam [USAN:USP:INN:BAN]
Temazepam 1.0 mg/ml in Methanol
Temazepam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Temazepam, analytical standard
Temazepam, British Pharmacopoeia (BP) Reference Standard
Temazepam, pharmaceutical grade
Temazepam, United States Pharmacopeia (USP) Reference Standard
Temazepam; T8275_Sigma; Divk1c_000989; Ninds_000989
Temazepamum
Temazepamum [INN-Latin]
Temtabs
Tenox
Tox21_111670
Tox21_200044
Uvamin Retard
WLN: T67 GNV JN IHJ CG G1 IQ KR
WY 2917
WY 3917
Wy-3917

US Patents and Regulatory Information for temazepam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 071174-001 Jul 10, 1986 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs TEMAZEPAM temazepam CAPSULE;ORAL 071446-001 May 21, 1993 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novel Labs Inc TEMAZEPAM temazepam CAPSULE;ORAL 071456-001 Apr 21, 1987 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for temazepam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 ➤ Sign Up ➤ Sign Up
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 ➤ Sign Up ➤ Sign Up
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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