FDA.report

Application 018708

Type
NDA
Sponsor
GALT PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DORALQUAZEPAMTABLET;ORAL15MGYesYes
003DORALQUAZEPAMTABLET;ORAL7.5MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1474QuazepamQUAZEPAMA-S Medication Solutions LLCNDACurrent
61825-165DoralQuazepamGalt Pharmaceuticals LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
61825-165DORALQuazepamGalt Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent
71993-265QuazepamQuazepamAtland Pharmaceuticals, LLCNDACurrent

Documents

DocumentSubmission typeDate
73221SUPPL2023-01-17
73220SUPPL2023-01-17
73172SUPPL2023-01-17
66217SUPPL2021-02-16
66176SUPPL2021-02-10
66133SUPPL2021-02-09
57618ORIG2019-02-15
57597SUPPL2019-02-14
57479SUPPL2019-02-07
57478SUPPL2019-02-07
46642SUPPL2017-01-03
46467SUPPL2016-12-22
46316SUPPL2016-12-20
11290SUPPL2013-04-23
11289SUPPL2013-04-23
33570SUPPL2010-04-20
15109SUPPL2007-11-08
33569SUPPL2007-11-07
23542ORIG2007-03-16
15108SUPPL2003-07-29