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BACTRIM

NDA

SULFAMETHOXAZOLE; TRIMETHOPRIM | N017560 | SUN PHARMACEUTICAL INDUSTRIES INC

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2019-P-0198 Lachman Consultant Services, Inc., acting as the US Agent for NaviSci Pte Ltd, filed this petition requesting that the FDA designate an additional reference standard for Sulfamethoxazole and Trimethoprim Oral Suspension in the Orange Book to support an ANDA submission, citing that the current refere	Other	2019-01-14	Denied	Lachman Consultant Services, 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

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982