`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`201655Orig1s000
`
`
`ENVIRONMENTAL ASSESSMENT
`
`
`
`
`
`
`
`
`
`
`
`
`l .12 Other Correspondence
`
`14.
`
`ENVIRONMENTAL ASSESSMENT
`
`Claim for Categorical Exclusion of
`Oxymorphone Hydrochloride
`m4) Extended-Release Tablets
`5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg
`from the Environmental Assessment Requirements of 21 CFR 25.40
`
`In accordance with 21 CFR 25.31(b), Endo Pharmaceuticals Inc. claims a categorical exclusion
`from the environmental assessment requirements of 21 CFR 25.40 for approval of this
`application.
`
`Based upon the estimate of the highest quantity of the active moiety to be produced (for direct
`use) in the next 5 years, the estimated concentration of the active moiety at the point of entry into
`the aquatic environment will be below 1 part per billion (ppb). Therefore, this action is subject to
`a categorical exclusion and will not require the preparation of an environmental assessment. The
`figures used for this calculation are available upon request.
`
`To our knowledge, no extraordinary circumstances exist pertaining to this action.
`
`DQDEQl/Ifl't’a- $ee P052 77! a; ?/£7//0 WC fat/M
`
`(W.
`
`26-Apr-2010
`
`Endo Pharmaceuticals Inc.
`Confidential
`
`Page 1
`
`Reference ID: 3061 375
`
`
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