Is there a generic for Hydrocortisone probutate?

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

What is the reference-listed drug for Hydrocortisone probutate?

PANDEL (NDA 020453, ANI 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 probutate are approved?

Hydrocortisone probutate is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Hydrocortisone probutate

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

Reference-listed drug:PANDEL · NDA 020453

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
PANDELRLD	ANI PHARMS	NDA 020453	—	Feb 28, 1997

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 probutate — frequently asked questions

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

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