March 18, 2007 - 10:46am
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 |
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]