Viewing data from:

SULFATRIM PEDIATRIC

NDA

SULFAMETHOXAZOLE; TRIMETHOPRIM | N018615 | PHARMACEUTICAL ASSOCIATES 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 1 NDC

Highest NADAC/Unit

$0.0553

per ml

Lowest NADAC/Unit

$0.0553

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00121085416SULFATRIM PEDIATRIC SUSPENSION	$0.0553	ML	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$32.72

Highest Price

$32.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00121-0854-16SULFAMETHOXAZOLE 200MG/TRIMETHOPRIM 40MG/5ML	$32.72	FSS	Lovell Government Services Inc.	07/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 25, 2025	SUPPL -86	View Letter (PDF)
Jun 25, 2024	SUPPL -83	View Letter (PDF)
Oct 19, 2021	SUPPL -80	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 200MG/5ML;40MG/5ML

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jan 7, 1983

#001 — 200MG/5ML;40MG/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jan 7, 1983

No patent or exclusivity listings for this strength.