Is there a generic for Trimethoprim hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Trimethoprim hydrochloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Trimethoprim hydrochloride?

PRIMSOL (NDA 074973, PANGEA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trimethoprim hydrochloride are approved?

Trimethoprim hydrochloride is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Trimethoprim hydrochloride

Trimethoprim hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PRIMSOL · NDA 074973

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
PRIMSOLRLD	PANGEA	NDA 074973	—	Jan 24, 2000
PRIMSOL	PANGEA	NDA 074374	—	Jun 23, 1995

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.

Trimethoprim hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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