Methazolamide Oral Tablet

Brand(s)
Neptazane
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2015-01-27)
Oldest Current Product
1993-06-30
License(s)
ANDA
RxNORM
ORAL TABLET\METHAZOLAMIDE
FDAOB
ORAL\TABLET\METHAZOLAMIDE
SPL Active
ORAL\TABLET\METHAZOLAMIDE
SPL Moiety
ORAL\TABLET\METHAZOLAMIDE

product(s) by strength(s)

methazolamide 25 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740786NeptazaneANDAPaddock Laboratories, Llc2015-01-12METHAZOLAMIDEORALTABLETANDA0400627731560b-dbe7-4912-814e-ef60629e5f07
2005740790ANDAPaddock Laboratories, Llc2014-09-30METHAZOLAMIDEORALTABLETANDA0400625e0795e1-d5c5-4b04-9bce-077bb8028023
3007811072ANDASandoz Inc1993-06-30METHAZOLAMIDEORALTABLETANDA0400364c9fc6f5-acd4-4fc0-bf4b-c493a08aa3d6
4481020014NeptazaneANDAFera Pharmaceuticals2010-06-22METHAZOLAMIDEORALTABLETANDA0400622af064d6-c0ee-45a9-8652-3869fffc5b74
5481020100ANDAFera Pharmaceuticals2010-06-22METHAZOLAMIDEORALTABLETANDA0400622d620e91-b5ad-40a9-a93e-ee675e1fd5cf
6558060021ANDAEffcon Laboratories, Inc.1994-07-14METHAZOLAMIDEORALTABLETANDA0400628e162b6d-8fa6-45f6-80d8-5132d94c1207
7625590240ANDAAnip Acquisition Company2014-11-06METHAZOLAMIDEORALTABLETANDA040001c26c8834-961e-4c9c-9ad4-5db2d9419938

methazolamide 50 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740787NeptazaneANDAPaddock Laboratories, Llc2015-01-12METHAZOLAMIDEORALTABLETANDA0400627731560b-dbe7-4912-814e-ef60629e5f07
2005740791ANDAPaddock Laboratories, Llc2014-09-30METHAZOLAMIDEORALTABLETANDA0400625e0795e1-d5c5-4b04-9bce-077bb8028023
3007811071ANDASandoz Inc1993-06-30METHAZOLAMIDEORALTABLETANDA0400364c9fc6f5-acd4-4fc0-bf4b-c493a08aa3d6
4481020015NeptazaneANDAFera Pharmaceuticals2010-06-22METHAZOLAMIDEORALTABLETANDA0400622af064d6-c0ee-45a9-8652-3869fffc5b74
5481020101ANDAFera Pharmaceuticals2010-06-22METHAZOLAMIDEORALTABLETANDA0400622d620e91-b5ad-40a9-a93e-ee675e1fd5cf
6558060020ANDAEffcon Laboratories, Inc.1994-07-18METHAZOLAMIDEORALTABLETANDA0400628e162b6d-8fa6-45f6-80d8-5132d94c1207
7625590241ANDAAnip Acquisition Company2014-11-06METHAZOLAMIDEORALTABLETANDA040001c26c8834-961e-4c9c-9ad4-5db2d9419938

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682996ANDAPhysicians Total Care, Inc.2006-12-12METHAZOLAMIDEORALTABLET007811071ANDA040036ec5e2032-3273-4364-be63-44766750650d
2681513110ANDACarilion Materials Management2010-06-22METHAZOLAMIDEORALTABLET481020101ANDA0400624311658f-8f74-47ad-b38b-17ffa5cdb72f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040001METHAZOLAMIDEANI PHARMACEUTICALS INC1993-06-30ANDA040001_001, ANDA040001_002
2ANDA040011METHAZOLAMIDETrueAPPLIED ANALYTICAL INDUSTRIES1997-07-17ANDA040011_001, ANDA040011_002
3ANDA040036METHAZOLAMIDESANDOZ INC1993-06-30ANDA040036_001, ANDA040036_002
4ANDA040062METHAZOLAMIDEMIKART INC1994-01-27ANDA040062_001, ANDA040062_002
5ANDA040102METHAZOLAMIDETrueSANDOZ INC1996-08-28ANDA040102_001, ANDA040102_002
6NDA011721NEPTAZANETrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID CONDA011721_001, NDA011721_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040001_001RXMETHAZOLAMIDE (25MG)ORALTABLETFalseAB1993-06-30METHAZOLAMIDE
2ANDA040001_002RXMETHAZOLAMIDE (50MG)ORALTABLETFalseAB1993-06-30METHAZOLAMIDE
3ANDA040011_001discontinuedMETHAZOLAMIDE (25MG)ORALTABLETFalse1997-07-17METHAZOLAMIDE
4ANDA040011_002discontinuedMETHAZOLAMIDE (50MG)ORALTABLETFalse1997-07-17METHAZOLAMIDE
5ANDA040036_001RXMETHAZOLAMIDE (25MG)ORALTABLETFalseAB1993-06-30METHAZOLAMIDE
6ANDA040036_002RXMETHAZOLAMIDE (50MG)ORALTABLETFalseAB1993-06-30METHAZOLAMIDE
7ANDA040062_001RXMETHAZOLAMIDE (25MG)ORALTABLETFalseAB1994-01-27METHAZOLAMIDE
8ANDA040062_002RXMETHAZOLAMIDE (50MG)ORALTABLETTrueAB1994-01-27METHAZOLAMIDE
9ANDA040102_001discontinuedMETHAZOLAMIDE (25MG)ORALTABLETFalse1996-08-28METHAZOLAMIDE
10ANDA040102_002discontinuedMETHAZOLAMIDE (50MG)ORALTABLETFalse1996-08-28METHAZOLAMIDE
11NDA011721_001discontinuedMETHAZOLAMIDE (50MG)ORALTABLETFalseNEPTAZANE
12NDA011721_002discontinuedMETHAZOLAMIDE (25MG)ORALTABLETFalse1991-11-25NEPTAZANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12af064d6-c0ee-45a9-8652-3869fffc5b74 (view SPL)NEPTAZANETM Methazolamide Tablets USP25 mg and 50 mgprescriptionHuman PrescriptionFera Pharmaceuticals2010-06-221481020014, 481020015
22d620e91-b5ad-40a9-a93e-ee675e1fd5cf (view SPL)METHAZOLAMIDE TABLETS USP25 mg and 50 mgprescriptionHuman PrescriptionFera Pharmaceuticals2010-06-222481020100, 481020101
34311658f-8f74-47ad-b38b-17ffa5cdb72f (view SPL)METHAZOLAMIDE TABLETS USP 25 mg and 50 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-06-222681513110
44c9fc6f5-acd4-4fc0-bf4b-c493a08aa3d6 (view SPL)Methazolamide Tablets, USPprescriptionHuman PrescriptionSandoz Inc2011-10-2011007811071, 007811072
55e0795e1-d5c5-4b04-9bce-077bb8028023 (view SPL)METHAZOLAMIDE TABLETS USP 25 mg and 50 mg Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-10-142005740790, 005740791
67731560b-dbe7-4912-814e-ef60629e5f07 (view SPL)NEPTAZANE Methazolamide Tablets USP 25 mg and 50 mg Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-01-271005740786, 005740787
78e162b6d-8fa6-45f6-80d8-5132d94c1207 (view SPL)prescriptionHuman PrescriptionEffcon Laboratories, Inc.2013-12-302558060020, 558060021
8c26c8834-961e-4c9c-9ad4-5db2d9419938 (view SPL)Methazolamide Tablets USP Rx onlyprescriptionHuman PrescriptionAnip Acquisition CompanyANALYSIS, LABEL, MANUFACTURE, PACK2014-11-061625590240, 625590241
9ec5e2032-3273-4364-be63-44766750650d (view SPL)Methazolamide Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-141548682996

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