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FDA Orange Book · active-ingredient family

Neomycin sulfate; prednisolone acetate

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

0

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
NEO-DELTA-CORTEF×2PHARMACIA AND UPJOHNANDA 061039Approved Prior to Jan 1, 1982
NEO-DELTA-CORTEFPHARMACIA AND UPJOHNANDA 061037Approved 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.

Neomycin sulfate; prednisolone acetate — frequently asked questions

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

Agent CTA Background

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