Is there a generic for Pemoline?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Pemoline, referencing the brand CYLERT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Pemoline?

CYLERT (NDA 017703, ABBOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pemoline are approved?

Pemoline is approved in the following dosage forms: tablet, tablet, chewable.

FDA Orange Book · active-ingredient family

Pemoline

Pemoline is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CYLERT · NDA 017703

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet, tablet, chewable

Product	Applicant	Application	TE	Approved
CYLERT	ABBOTT	NDA 017703	—	Approved Prior to Jan 1, 1982
CYLERT×3	ABBOTT	NDA 016832	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (8)

Product	Applicant	Application	TE	Approved
PEMOLINE×3	WATSON LABS	ANDA 075287	—	Jun 13, 2001
PEMOLINE×3	MALLINCKRODT	ANDA 075726	—	Mar 30, 2001
PEMOLINE	ACTAVIS ELIZABETH	ANDA 075678	—	Jul 26, 2000
PEMOLINE×3	VINTAGE PHARMS	ANDA 075328	—	Apr 19, 2000
PEMOLINE×3	ACTAVIS ELIZABETH	ANDA 075595	—	Feb 28, 2000
PEMOLINE×3	TEVA PHARMS	ANDA 075030	—	Feb 22, 2000
PEMOLINE	TEVA PHARMS	ANDA 075555	—	Feb 18, 2000
PEMOLINE×3	FOSUN PHARMA	ANDA 075286	—	Dec 27, 1999

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.

Pemoline — frequently asked questions

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

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