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FDA Orange Book · active-ingredient family

Neomycin sulfate; prednisolone sodium phosphate

Neomycin sulfate; prednisolone sodium phosphate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NEO-HYDELTRASOL · NDA 050378

1

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · ointment

ProductApplicantApplicationTEApproved
NEO-HYDELTRASOLMERCKNDA 050378Approved 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 sodium phosphate — 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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