Friday, September 08, 2017 6:43:33 PM
From WeeZulh's link the FDA has "officially received" $ELTP's Percocet filing and $ELTP has seven days to correct the FDA cited "Minor Amendment" for the FDA to proceed with formal approval and follow-up new Inspection if required.
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352.pdf
Recent ELTP News
- Form 8-K - Current report • Edgar (US Regulatory) • 04/02/2026 12:05:23 PM
- Elite Pharmaceuticals Announces Commercial Launch of Methadone Hydrochloride Tablets • Newsfile • 04/02/2026 12:00:00 PM
- 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
- Form 8-K - Current report • Edgar (US Regulatory) • 06/30/2025 08:27:51 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 06/30/2025 08:05:59 PM
