Is there a generic for Bacitracin; polymyxin b sulfate?

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

What is the reference-listed drug for Bacitracin; polymyxin b sulfate?

LANABIOTIC (NDA 050598, COMBE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Bacitracin; polymyxin b sulfate are approved?

Bacitracin; polymyxin b sulfate is approved in the following dosage form: disc.

FDA Orange Book · active-ingredient family

Bacitracin; polymyxin b sulfate

Bacitracin; polymyxin b sulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LANABIOTIC · NDA 050598

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · disc

Product	Applicant	Application	TE	Approved
LANABIOTIC	COMBE	NDA 050598	—	Sep 22, 1986

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.

Bacitracin; polymyxin b sulfate — frequently asked questions

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

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