Demeclocycline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amneal Pharmaceuticals (2012-12-21)
Oldest Current Product
2004-03-22
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DEMECLOCYCLINE
FDAOB
ORAL\TABLET\DEMECLOCYCLINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\DEMECLOCYCLINE HYDROCHLORIDE
ORAL\TABLET\DEMECLOCYCLINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\DEMECLOCYCLINE
ORAL\TABLET\DEMECLOCYCLINE

product(s) by strength(s)

demeclocycline hydrochloride 150 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001152111ANDAGlobal Pharmaceuticals2004-03-22DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065094641263c2-b423-4f44-95a3-d67da235ddb0
2005550701ANDABarr Laboratories Inc.2005-01-04DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065171ec16fd0b-9185-4fed-a702-770b4fb1a1cd
3428060143ANDAEpic Pharma, Llc2015-02-02DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065447645af8f4-0843-4afb-9ddc-f587f38adb68
4617480115ANDAVersapharm Incorporated2008-12-15DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0653891a4ce717-7a29-4308-8180-91f923d45a03
5651620554ANDAAmneal Pharmaceuticals2008-02-27DEMECLOCYCLINE HYDROCHLORIDEORALTABLETANDA0654254ff23e3b-e111-47fd-9776-1d89d6da049b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200334NDACorepharma, Llc2012-09-18DEMECLOCYCLINE HYDROCHLORIDEORALTABLETNDA0502615e13a6b0-f4dc-4602-b8dd-013013ae149a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1625840159ANDAAmerican Health Packaging2010-11-30DEMECLOCYCLINE HYDROCHLORIDEORALTABLET651620554ANDA06542585221ba6-8417-499a-9f74-b2d714a7a560
2681510155ANDACarilion Materials Management2010-04-01DEMECLOCYCLINE HYDROCHLORIDEORALTABLET651620554ANDA065425b60e9a8b-c315-40a8-baa1-d0739489b293

demeclocycline hydrochloride 300 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001152122ANDAGlobal Pharmaceuticals2004-03-22DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065094641263c2-b423-4f44-95a3-d67da235ddb0
2005550702ANDABarr Laboratories Inc.2005-01-04DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065171ec16fd0b-9185-4fed-a702-770b4fb1a1cd
3009046181ANDAMajor2010-11-19DEMECLOCYCLINE HYDROCHLORIDEORALTABLETANDA06542510aa63df-86be-4f78-9e2d-6daa07c4a7dc
4428060144ANDAEpic Pharma, Llc2015-02-02DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA065447645af8f4-0843-4afb-9ddc-f587f38adb68
5617480113ANDAVersapharm Incorporated2008-12-15DEMECLOCYCLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0653891a4ce717-7a29-4308-8180-91f923d45a03
6651620555ANDAAmneal Pharmaceuticals2008-02-27DEMECLOCYCLINE HYDROCHLORIDEORALTABLETANDA0654254ff23e3b-e111-47fd-9776-1d89d6da049b

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200335NDACorepharma, Llc2012-09-18DEMECLOCYCLINE HYDROCHLORIDEORALTABLETNDA0502615e13a6b0-f4dc-4602-b8dd-013013ae149a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1625840163ANDAAmerican Health Packaging2010-12-15DEMECLOCYCLINE HYDROCHLORIDEORALTABLET651620555ANDA06542585221ba6-8417-499a-9f74-b2d714a7a560

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA065094DEMECLOCYCLINE HYDROCHLORIDEIMPAX LABORATORIES INC2004-03-22ANDA065094_001, ANDA065094_002
2ANDA065171DEMECLOCYCLINE HYDROCHLORIDEBARR LABORATORIES INC2004-12-13ANDA065171_001, ANDA065171_002
3ANDA065389DEMECLOCYCLINE HYDROCHLORIDEVERSAPHARM INC2008-12-01ANDA065389_001, ANDA065389_002
4ANDA065425DEMECLOCYCLINE HYDROCHLORIDEAMNEAL PHARMACEUTICAL2008-02-27ANDA065425_001, ANDA065425_002
5ANDA065447DEMECLOCYCLINE HYDROCHLORIDEEPIC PHARMA LLC2015-08-18ANDA065447_001, ANDA065447_002
6NDA050261DECLOMYCINTrueCOREPHARMA LLCNDA050261_001, NDA050261_002, NDA050261_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA065094_001RXDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2004-03-22DEMECLOCYCLINE HYDROCHLORIDE
2ANDA065094_002RXDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2004-03-22DEMECLOCYCLINE HYDROCHLORIDE
3ANDA065171_001RXDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2004-12-13DEMECLOCYCLINE HYDROCHLORIDE
4ANDA065171_002RXDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2004-12-13DEMECLOCYCLINE HYDROCHLORIDE
5ANDA065389_001RXDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2008-12-01DEMECLOCYCLINE HYDROCHLORIDE
6ANDA065389_002RXDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2008-12-01DEMECLOCYCLINE HYDROCHLORIDE
7ANDA065425_001RXDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2008-02-27DEMECLOCYCLINE HYDROCHLORIDE
8ANDA065425_002RXDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETTrueAB2008-02-27DEMECLOCYCLINE HYDROCHLORIDE
9ANDA065447_001RXDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseAB2015-08-18DEMECLOCYCLINE HYDROCHLORIDE
10ANDA065447_002RXDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETFalseAB2015-08-18DEMECLOCYCLINE HYDROCHLORIDE
11NDA050261_001discontinuedDEMECLOCYCLINE HYDROCHLORIDE (75MG)ORALTABLETFalseDECLOMYCIN
12NDA050261_002discontinuedDEMECLOCYCLINE HYDROCHLORIDE (150MG)ORALTABLETFalseDECLOMYCIN
13NDA050261_003discontinuedDEMECLOCYCLINE HYDROCHLORIDE (300MG)ORALTABLETFalseDECLOMYCIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
110aa63df-86be-4f78-9e2d-6daa07c4a7dc (view SPL)DEMECLOCYCLINE HYDROCHLORIDE Tablets, USP (Film Coated)prescriptionHuman PrescriptionMajor2012-07-203009046181
21a4ce717-7a29-4308-8180-91f923d45a03 (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP (FILM COATED)prescriptionHuman PrescriptionVersapharm IncorporatedMANUFACTURE2014-11-114617480113, 617480115
34ff23e3b-e111-47fd-9776-1d89d6da049b (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK, REPACK2012-12-215651620554, 651620555
45e13a6b0-f4dc-4602-b8dd-013013ae149a (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP FOR ORAL USERX ONLYprescriptionHuman PrescriptionCorepharma, Llc2012-10-022647200334, 647200335
5641263c2-b423-4f44-95a3-d67da235ddb0 (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS USP, 150 MG and 300 MGprescriptionHuman PrescriptionGlobal PharmaceuticalsREPACK2012-01-192001152111, 001152122
6645af8f4-0843-4afb-9ddc-f587f38adb68 (view SPL)Demeclocycline Hydrochloride TabletsRx OnlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-08-173428060143, 428060144
785221ba6-8417-499a-9f74-b2d714a7a560 (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USPFOR ORAL USEprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-072625840159, 625840163
8b60e9a8b-c315-40a8-baa1-d0739489b293 (view SPL)DEMECLOCYCLINE HYDROCHLORIDE Tablets, USP (Film Coated)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-04-012681510155
9ec16fd0b-9185-4fed-a702-770b4fb1a1cd (view SPL)DEMECLOCYCLINE HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2012-12-055005550701, 005550702

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