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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050719-001HELIDACBISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE262.4MG,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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE, TABLET, CAPSULE / ORALRLD1996-08-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050719-001HELIDAC262.4MG,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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE, TABLET, CAPSULE / ORALRLD1996-08-15a50c72e98297…

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