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First-Time Generics - February 2007

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First-Time Generic Approvals - February 2007

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
SERTRALINE HYDROCHLORIDE TABLETS, 150 MG (BASE) AND 200 MG (BASE) (see Note) RANBAXY ZOLOFT TABLETS 02-06-07
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG TEVA ACIPHEX DELAYED-RELEASE TABLETS 02-21-07
CITALOPRAM HYDROBROMIDE CAPSULES, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) ALPHAPHARM CELEXA TABLETS 02-28-07

Source: US Food and Drug Administration



Pharmer.org Pill Identifier



Citalopram Note: Our citalopram table lists tablets only; Alphapharm's citalopram is the first generic to be marketed in the United States in capsule form.

Sertraline Note: Pfizer received a new drug application (NDA 19-839) for 150 mg and 200 mg sertraline (Zoloft) in December 1991. Pfizer never marketed these dosage forms, and the FDA left open the possibility that generic sertraline 150 mg and 200 mg could later be approved by the agency. Please see Federal Register: September 17, 2004 (Volume 69, Number 180) [Notices]