Is Bactrim Pediatric still available?

Bactrim Pediatric (NDA 017560) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

What is Bactrim Pediatric's FDA application number?

Bactrim Pediatric is approved under NDA 017560, held by Sun Pharm Industries.

Orange Book product · Brand (NDA)

Bactrim Pediatric

Sulfamethoxazole; Trimethoprim

Brand (NDA)NDA 017560Discontinued Sun Pharm Industries

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Bactrim Pediatric (Sulfamethoxazole; Trimethoprim) is Sun Pharm Industries's brand-name drug, approved by the FDA under NDA 017560. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 40 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Strength

200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 017560

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 017560

200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Sulfamethoxazole; Trimethoprim family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.