Viewing data from:

SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE

NDA

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM | N021105 | ABLE LABORATORIES INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Guvam Pharma, LLC FDA-2019-P-5791 · 7 docket documents Guvam Pharma LLC filed this ANDA Suitability Petition on December 6, 2019, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA determine Phenazopyridine Hydrochloride Tablets in 50 mg, 100 mg, and 200 mg strengths are suitable	Other	2019-12-09	Denied	Guvam Pharma, LLC
Citizen Petition from JRRapoza Associates, Inc. FDA-2007-P-0353 · 6 docket documents JRRapoza Associates, Inc. filed this citizen petition on January 17, 2007, requesting that the FDA Commissioner determine whether three drug products—Azo Gantanal (NDA 13-294), Azo Gantrisin (NDA 19-358), and Phenazopyridine HCl/Sulfamethoxazole/Trimethoprim Tablets 200mg/800mg/160mg (NDA 21-105)—we	Other	2008-06-10	Withdrawn	JRRapoza Associates, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 26, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG,N/A,N/A;N/A,800MG,160MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 26, 2001

No patent or exclusivity listings for this strength.