Is there a generic for Neomycin sulfate; polymyxin b sulfate?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Neomycin sulfate; polymyxin b sulfate, referencing the brand NEOSPORIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

NEOSPORIN (NDA 050176, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

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

Neomycin sulfate; polymyxin b sulfate is approved in the following dosage forms: cream, ointment, solution, solution/drops.

FDA Orange Book · active-ingredient family

Neomycin sulfate; polymyxin b sulfate

Neomycin sulfate; polymyxin b sulfate: 3 brands, 5 generics; first approved Nov 30, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

NEOSPORIN

GLAXOSMITHKLINENDA 0501761985

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3.5MG BASE/GM;10,000 UNITS/GM	CREAM	TOPICAL	Discontinued	—

STATROL

ALCONNDA 050344—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT	OPHTHALMIC	Discontinued	—

STATROL

ALCONNDA 050456—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3.5MG BASE/ML;16,250 UNITS/ML	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

NEOMYCIN AND POLYMYXIN B SULFATERS

XGEN PHARMSANDA 0651062006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION	IRRIGATION	Rx	—

NEOMYCIN AND POLYMYXIN B SULFATERS

XGEN PHARMSANDA 0651082006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION	IRRIGATION	Rx	—

NEOMYCIN AND POLYMYXIN B SULFATE

WATSON LABSANDA 0626641986

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION	IRRIGATION	Discontinued	—

STATROL

ALCONANDA 0623391984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3.5MG BASE/ML;16,250 UNITS/ML	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

NEOSPORIN G.U. IRRIGANT

MONARCH PHARMSANDA 060707—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML;200,000 UNITS/ML	SOLUTION	IRRIGATION	Discontinued	—

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.

FDA approval span

Approval history

First approval

Nov 30, 1984

42 yr 3 mo ago

Most recent approval

Jan 31, 2006

20 yr 9 mo ago

Approvals span 1984–2006 across 8 FDA applications.

Brand (NDA) 338%

Generic (ANDA) 563%

Neomycin sulfate; polymyxin b sulfate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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