Is there a generic for Carteolol hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Carteolol hydrochloride, referencing the brand OCUPRESS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Carteolol hydrochloride?

OCUPRESS (NDA 019972, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Carteolol hydrochloride are approved?

Carteolol hydrochloride is approved in the following dosage forms: solution/drops, tablet.

FDA Orange Book · active-ingredient family

Carteolol hydrochloride

Carteolol hydrochloride is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:OCUPRESS · NDA 019972

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops, tablet

Product	Applicant	Application	TE	Approved
OCUPRESSRLD	NOVARTIS	NDA 019972	—	May 23, 1990
CARTROL×3	ABBVIE	NDA 019204	—	Dec 28, 1988

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
CARTEOLOL HYDROCHLORIDE	APOTEX INC	ANDA 076097	—	Feb 06, 2002
CARTEOLOL HYDROCHLORIDE	BAUSCH AND LOMB	ANDA 075546	—	Jan 20, 2000
CARTEOLOL HYDROCHLORIDE	SANDOZ	ANDA 075476	—	Jan 03, 2000

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.

Carteolol hydrochloride — frequently asked questions

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

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