Viewing data from:

HELIDAC

NDA

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | N050719 | CASPER PHARMA LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -26	View Letter (PDF)
Jul 9, 2024	SUPPL -25	View Letter (PDF)
Dec 20, 2021	SUPPL -24	View Letter (PDF)
Mar 9, 2021	SUPPL -23	View Letter (PDF)
Mar 15, 2019	SUPPL -22	View Letter (PDF)
Sep 10, 2015	SUPPL -21	View Letter (PDF)
Jan 21, 2010	SUPPL -15	View Letter (PDF)
Jul 1, 2008	SUPPL -13	View Letter (PDF)
Jul 27, 2007	SUPPL -9	View Letter (PDF)
Sep 15, 2004	SUPPL -8	View Letter (PDF)
Jun 7, 2004	ORIG -1	View Letter (PDF)
Jun 7, 2004	SUPPL -6	View Letter (PDF)
May 29, 2003	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | Approved: Aug 15, 1996

No patent or exclusivity listings for this strength.