federal_register: 2020-27082
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-27082 | Allergan Pharmaceuticals International, Ltd.; Withdrawal of Approval of a New Drug Application for ASACOL (Mesalamine) Delayed-Release Tablets, 400 Milligrams | Notice | The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA's request, Allergan agreed to withdrawal of this application and has waived its opportunity for a hearing. | 2020-12-10 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/10/2020-27082/allergan-pharmaceuticals-international-ltd-withdrawal-of-approval-of-a-new-drug-application-for | https://www.govinfo.gov/content/pkg/FR-2020-12-10/pdf/2020-27082.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,... |