federal_register: 2017-25771
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-25771 | Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams | Notice | The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 020932 for ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc. (Roxane). Roxane requested withdrawal of this application and waived its opportunity for a hearing. | 2017-11-29 | 2017 | 11 | https://www.federalregister.gov/documents/2017/11/29/2017-25771/roxane-laboratories-inc-withdrawal-of-approval-of-a-new-drug-application-for-roxicodone-oxycodone | https://www.govinfo.gov/content/pkg/FR-2017-11-29/pdf/2017-25771.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 020932 for ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc.... |