Is there a generic for Prednisolone tebutate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Prednisolone tebutate, referencing the brand HYDELTRA-TBA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Prednisolone tebutate?

HYDELTRA-TBA (NDA 010562, MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Prednisolone tebutate are approved?

Prednisolone tebutate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Prednisolone tebutate

Prednisolone tebutate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HYDELTRA-TBA · NDA 010562

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HYDELTRA-TBA	MERCK	NDA 010562	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
PREDNISOLONE TEBUTATE	WATSON LABS	ANDA 083362	—	Feb 17, 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.

Prednisolone tebutate — frequently asked questions

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

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