FDA.reportPublic FDA data

Application 050719

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HELIDACBISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDETABLET, CHEWABLE, TABLET, CAPSULE;ORAL262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81854SUPPL 2025-04-08
81792SUPPL 2025-04-02
79026SUPPL 2024-07-09
79011SUPPL 2024-07-09
69680SUPPL2021-12-20
69582SUPPL2021-12-16
66700SUPPL2021-03-09
66660SUPPL2021-03-09
58010SUPPL2019-03-15
58006SUPPL2019-03-15
58003SUPPL2019-03-15
48682ORIG2017-06-09
30361SUPPL2015-09-10
18110SUPPL2015-08-12
18108SUPPL2012-06-26
18109SUPPL2012-06-20
30360SUPPL2010-01-21
39180SUPPL2009-11-16
30359SUPPL2008-07-01
18107SUPPL2008-06-30
8098SUPPL2007-07-27
39179SUPPL2004-09-15
30358SUPPL2004-09-15
8097SUPPL2004-06-07
8096ORIG2004-06-07
30357SUPPL2003-05-29
39178SUPPL2003-05-06
39177SUPPL2002-12-12