Is there a generic for Carbenicillin disodium?

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

What is the reference-listed drug for Carbenicillin disodium?

GEOPEN (NDA 050306, ROERIG) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Carbenicillin disodium are approved?

Carbenicillin disodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Carbenicillin disodium

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

Reference-listed drug:GEOPEN · NDA 050306

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
GEOPEN×5	ROERIG	NDA 050306	—	Approved Prior to Jan 1, 1982
PYOPEN×5	GLAXOSMITHKLINE	NDA 050298	—	Approved Prior to Jan 1, 1982

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.

Carbenicillin disodium — frequently asked questions

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

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