Is there a generic for Gentamicin sulfate; prednisolone acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gentamicin sulfate; prednisolone acetate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Gentamicin sulfate; prednisolone acetate?

PRED-G (NDA 050612, ALLERGAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gentamicin sulfate; prednisolone acetate are approved?

Gentamicin sulfate; prednisolone acetate is approved in the following dosage forms: ointment, suspension/drops.

FDA Orange Book · active-ingredient family

Gentamicin sulfate; prednisolone acetate

Gentamicin sulfate; prednisolone acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PRED-G · NDA 050612

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · ointment, suspension/drops

Product	Applicant	Application	TE	Approved
PRED-GRLD	ALLERGAN	NDA 050612	—	Dec 01, 1989
PRED-GRLD	ALLERGAN	NDA 050586	—	Jun 10, 1988

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.

Gentamicin sulfate; prednisolone acetate — frequently asked questions

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

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