Application 050719

Type: NDA
Sponsor: CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HELIDAC	BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	TABLET, CHEWABLE, TABLET, CAPSULE;ORAL	262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050719-001	HELIDAC	BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL		RLD	1996-08-15

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050719-001	HELIDAC	262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RLD	1996-08-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050719-001	HELIDAC	262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RLD	1996-08-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050719-001	HELIDAC	262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE, TABLET, CAPSULE / ORAL	RLD	1996-08-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050719-001	HELIDAC	262.4MG,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 / ORAL	RLD	1996-08-15	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81854	SUPPL	2025-04-08
81792	SUPPL	2025-04-02
79026	SUPPL	2024-07-09
79011	SUPPL	2024-07-09
69680	SUPPL	2021-12-20
69582	SUPPL	2021-12-16
66700	SUPPL	2021-03-09
66660	SUPPL	2021-03-09
58010	SUPPL	2019-03-15
58006	SUPPL	2019-03-15
58003	SUPPL	2019-03-15
48682	ORIG	2017-06-09
30361	SUPPL	2015-09-10
18110	SUPPL	2015-08-12
18108	SUPPL	2012-06-26
18109	SUPPL	2012-06-20
30360	SUPPL	2010-01-21
39180	SUPPL	2009-11-16
30359	SUPPL	2008-07-01
18107	SUPPL	2008-06-30
8098	SUPPL	2007-07-27
39179	SUPPL	2004-09-15
30358	SUPPL	2004-09-15
8097	SUPPL	2004-06-07
8096	ORIG	2004-06-07
30357	SUPPL	2003-05-29
39178	SUPPL	2003-05-06
39177	SUPPL	2002-12-12