Friday, December 29, 2017 9:46:45 AM
Weird.
This looks like a brand new ANDA for phendimetrazine 35mg tablets. Elite acquired an ANDA for phendimetrazine 35mg tablets as one of the 13 ANDA's that came with Nasrat Hakim and Mikah back in August 2013. Hopefully we'll get an explanation via PR later today or next week.
Elite's "Bontril" has been around for years now. Don't know why this got posted by the FDA as new approval
This looks like a brand new ANDA for phendimetrazine 35mg tablets. Elite acquired an ANDA for phendimetrazine 35mg tablets as one of the 13 ANDA's that came with Nasrat Hakim and Mikah back in August 2013. Hopefully we'll get an explanation via PR later today or next week.
Call on God but row away from the rocks.
-Hunter S. Thompson
Recent ELTP News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/01/2026 11:00:24 AM
- Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product • Newsfile • 06/01/2026 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/02/2026 12:05:23 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 02/17/2026 10:10:32 PM
- Elite Pharmaceuticals, Inc. Reports Financial Results for the Third Quarter of Fiscal Year 2026 (three months ended December 31, 2025) and Provides Conference Call Information • Newsfile • 02/17/2026 09:19:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/17/2026 09:06:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/11/2026 09:35:26 PM
- Elite Pharmaceuticals, Inc. to Host Conference Call to Provide Corporate Update and Discuss Third Quarter 2026 Financial Results on February 18, 2026 • Newsfile • 02/11/2026 09:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2026 09:35:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2025 10:10:23 PM
- Elite Pharmaceuticals, Inc. Reports Financial Results for the Second Quarter of Fiscal Year 2026 Ended September 30, 2025 and Provides Conference Call Information • Newsfile • 11/14/2025 09:19:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:11:38 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 11/12/2025 10:19:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/12/2025 12:15:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/10/2025 12:15:46 PM
- Elite Pharmaceuticals, Inc. to Host Conference Call to Provide Corporate Update and Discuss Second Quarter 2026 Financial Results on November 17, 2025 • Newsfile • 11/10/2025 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/26/2025 09:17:39 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/22/2025 01:39:01 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2025 08:37:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2025 08:35:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/25/2025 10:05:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/10/2025 08:17:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/08/2025 08:15:11 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/08/2025 02:58:10 PM
