Is there a generic for Acyclovir; hydrocortisone?

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

What is the reference-listed drug for Acyclovir; hydrocortisone?

XERESE (NDA 022436, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Acyclovir; hydrocortisone are approved?

Acyclovir; hydrocortisone is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Acyclovir; hydrocortisone

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

Reference-listed drug:XERESE · NDA 022436

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
XERESERLD	BAUSCH	NDA 022436	—	Jul 31, 2009

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.

Acyclovir; hydrocortisone — frequently asked questions

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

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