Is there a generic for Amdinocillin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Amdinocillin. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Amdinocillin?

COACTIN (NDA 050565, ROCHE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amdinocillin are approved?

Amdinocillin is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Amdinocillin

Amdinocillin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:COACTIN · NDA 050565

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
COACTIN×3	ROCHE	NDA 050565	—	Dec 21, 1984

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.

Amdinocillin — frequently asked questions

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

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