Is there a generic for Doxapram hydrochloride?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Doxapram hydrochloride, referencing the brand DOPRAM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Doxapram hydrochloride?

DOPRAM (NDA 014879, HIKMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Doxapram hydrochloride are approved?

Doxapram hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Doxapram hydrochloride

Doxapram hydrochloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DOPRAM · NDA 014879

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DOPRAMRLD	HIKMA	NDA 014879	AP	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
DOXAPRAM HYDROCHLORIDE	CHARTWELL INJECTABLE	ANDA 076266	AP	Jan 10, 2003
DOXAPRAM HYDROCHLORIDE	WATSON LABS	ANDA 073529	—	Jan 30, 1992

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.

Doxapram hydrochloride — frequently asked questions

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

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