Is there a generic for Hydrocortisone; neomycin sulfate?

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

What is the reference-listed drug for Hydrocortisone; neomycin sulfate?

NEO-CORT-DOME (NDA 050237, BAYER PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydrocortisone; neomycin sulfate are approved?

Hydrocortisone; neomycin sulfate is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Hydrocortisone; neomycin sulfate

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

Reference-listed drug:NEO-CORT-DOME · NDA 050237

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
NEO-CORT-DOME×2	BAYER PHARMS	NDA 050237	—	Jun 05, 1984

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.

Hydrocortisone; neomycin sulfate — frequently asked questions

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

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