Is there a generic for Cyclacillin?

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

What is the reference-listed drug for Cyclacillin?

CYCLAPEN-W (NDA 050508, WYETH AYERST) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cyclacillin are approved?

Cyclacillin is approved in the following dosage forms: for suspension, tablet.

FDA Orange Book · active-ingredient family

Cyclacillin

Cyclacillin: 2 brands, 1 generic; first approved Aug 04, 1988; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 1 ANDA application approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CYCLAPEN-W

WYETH AYERSTNDA 050508—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG/5ML	FOR SUSPENSION	ORAL	Discontinued	—
250MG/5ML	FOR SUSPENSION	ORAL	Discontinued	—
500MG/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CYCLAPEN-W

WYETH AYERSTNDA 050509—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (1)

CYCLACILLIN

TEVAANDA 06289519882 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG	TABLET	ORAL	Discontinued	—
500MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Aug 04, 1988

38 yr 6 mo ago

Most recent approval

Aug 04, 1988

38 yr 6 mo ago

All 3 applications were approved in 1988.

Brand (NDA) 267%

Generic (ANDA) 133%

Cyclacillin — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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