Elite Pharmaceuticals Inc (ELTP)

[lasers]

Embeda is 505b2 NDA


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf


"Please refer to your new drug application
(NDA) dated June 30, 2008, received June 30, 2008,
submitted pursuant to section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act for
EMBEDA (morphine sulfate and naltrexone hyd
rochloride) Extended-Release Capsules, 20
mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60
mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg. "