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Last Updated: January 20, 2020

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TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

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

Tetracycline hydrochloride is the generic ingredient in fourteen branded drugs marketed by Avet, Bristol, Warner Chilcott, Pharmacia And Upjohn, Solvay, Wyeth Ayerst, Apothecon, Angus, Abbott, Amneal Pharms Ny, Ani Pharms Inc, Breckenridge, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma Pharms, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Mylan, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Watson Labs, Pfipharmecs, Schiff And Co, Shire, Lederle, Pfizer, Storz, Par Pharm, Alpharma Us Pharms, and Proter, and is included in fifty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ninety-nine drug master file entries for tetracycline hydrochloride. Eight suppliers are listed for this compound.

Recent Clinical Trials for TETRACYCLINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kenya Medical Research InstitutePhase 4
Kenya National AIDS & STI Control ProgrammePhase 4
Paratek Pharmaceuticals IncPhase 1

See all TETRACYCLINE HYDROCHLORIDE clinical trials

Pharmacology for TETRACYCLINE HYDROCHLORIDE
Synonyms for TETRACYCLINE HYDROCHLORIDE
(-)-Tetrahcycline hydrochloride
(2E,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4,4a,5,5a-tetrahydrotetracene-1,3,12-trione hydrochloride
(2Z,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4,4a,5,5a-tetrahydrotetracene-1,3,12-trione hydrochloride
(4S,4aS,5aS,6S,12aS,Z)-2-(amino(hydroxy)methylene)-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trione hydrochloride
(4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride
(4S,4aS,5aS,6S,12aS)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide hydrochloride
(4S,4aS,5aS,6S,12aS)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride
(4S,6S,12aS,4aS,5aS)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,1 1-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide, chloride
102030-19-3
2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S-(4alpha,4aalpha,5aalpha,6beta,12aalpha))-
2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S-(4alpha,4aalpha,5aalpha,6beta,12alpha))-
2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S,4aS,5aS,6S,12aS)-
60-54-8 (Parent)
64-75-5
8017-77-4
8026-72-0
90438-83-8
AB1009394
AC1NQZPS
AC1NWAQJ
Achromycin
Achromycin hydrochloride
Actisite
AI3-50120
AKOS015951263
ALA TET
Artomycin
BCP0726000161
BCP9000227
Bristacycline (TN)
C22H24N2O8.HCl
Cancycline-250
CAS-64-75-5
CCG-39267
CCRIS 2351
Cefracycline tablets
CHEBI:34858
CHEMBL454950
Chlorhydrate de tetracycline
Chlorhydrate de tetracycline [French]
Chlorowodorku tetracykliny
Chlorowodorku tetracykliny [Polish]
CS-2588
D02122
Diacycine
DSSTox_CID_1321
DSSTox_GSID_21321
DSSTox_RID_76081
DTXSID6021321
Dumocyclin
EBD2198184
EC 200-593-8
EINECS 200-593-8
HMS1568K22
HMS1921C19
Hostacycline
HY-B0474
K044
KS-1431
MCULE-8111555447
Mephacyclin
MFCD00078142
MolPort-003-666-290
NCGC00016291-01
NCGC00017323-08
NCGC00180907-01
NCGC00180907-02
NCGC00258070-01
NCI-C55561
Neocyclin B
NSC-757338
NSC757338
P6R62377KV
Paltet
Panmycin hydrochloride
Partrex
Pharmakon1600-01500566
Piracaps
Polycycline hydrochloride
Polyotic ointment
Prestwick_434
Qidtet
Quadracycline
Remicyclin
Retet
Ricycline
Ro-Cycline
s2574
SBB006497
SC-19458
SCHEMBL34248
Sentry av ornacycline
SPECTRUM1500566
SR-01000000212
SR-01000000212-4
SR-05000001723
SR-05000001723-2
ST057166
ST24050122
Steclin
Stilciclina
Subamycin
Supramycin
Sustamycin
SW196293-4
T-250 Capsules
Tefilin
Teline
Telotrex
Tet-cy
Tetra-D
Tetra-wedel
Tetrabakat
Tetrabid
Tetrablet
Tetracaps
Tetraciclina cloridrato
Tetraciclina cloridrato [Italian]
Tetracompren
Tetracycline (hydrochloride)
Tetracycline chloride
Tetracycline HCl
Tetracycline hydrochloride (internal use)
Tetracycline hydrochloride (JP17/USP)
Tetracycline hydrochloride [USP:JAN]
Tetracycline hydrochloride, 'can be used as secondary standard'
Tetracycline hydrochloride, >=95% (European Pharmacopoeia HPLC assay)
Tetracycline hydrochloride, British Pharmacopoeia (BP) Reference Standard
Tetracycline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Tetracycline hydrochloride, meets USP testing specifications
Tetracycline hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Tetracycline hydrochloride, powder
Tetracycline hydrochloride, powder, BioReagent, suitable for cell culture
Tetracycline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Tetracycline hydrochloride, VETRANAL(TM), analytical standard
Tetracycline.HCl
Tetracyclinehydrochloride
Tetracyn hydrochloride
Tetrakap
Tetralution
Tetramavan
Tetramed
TetraSURE
Tetrosol
Topicycline
Tox21_110355
Tox21_110355_1
Tox21_200516
Triphacyclin
U-5965
Unicin
UNII-P6R62377KV
Vetquamycin-324

US Patents and Regulatory Information for TETRACYCLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferrante TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 060173-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Lederle ACHROMYCIN V tetracycline hydrochloride SUSPENSION;ORAL 050263-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs TETRACYCLINE HYDROCHLORIDE tetracycline hydrochloride CAPSULE;ORAL 060469-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>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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