SANTARUS INC Form 8-K: Current report
Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.
- 2009-12-07: Form 8-K; Period of report 2009-12-04; Description 8.01 Other Events; Details 8.01.
- 2009-12-02: Form 8-K; Period of report 2009-12-01; Description 8.01 Other Events; Details 8.01.
- 2009-11-30: Form 8-K; Period of report 2009-11-30; Description 8.01 Other Events; Details 8.01.
- 2009-11-10: Form 8-K; Period of report 2009-11-09; Description 8.01 Other Events; Details 8.01.
| Filed | Form | Period of report | Description | Details | Document |
|---|---|---|---|---|---|
| 2009-12-07 | 8-K | 2009-12-04 | 8.01 Other Events | 8.01 On December 4, 2009, Santarus, Inc. (“Santarus”) issued a press release announcing that that the U.S. Food and Drug Administration (“FDA”) approved Santarus’ New Drug Application (“NDA”) for immediate-release omeprazole/sodium bicarbonate/magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. | a54521e8vk.htm |
| 2009-12-02 | 8-K | 2009-12-01 | 8.01 Other Events | 8.01 On December 1, 2009, Santarus, Inc. (“Santarus”) issued a press release announcing that that the U.S. Food and Drug Administration approved a New Drug Application (“NDA”) submitted by Schering-Plough HealthCare Products, Inc., now part of Merck & Co., for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate). | a54496e8vk.htm |
| 2009-11-30 | 8-K | 2009-11-30 | 8.01 Other Events | 8.01 Santarus, Inc. (“Santarus”) was notified by Depomed, Inc. (“Depomed”) that Depomed has filed a lawsuit in the United States District Court for the Northern District of California against Lupin Limited and its wholly-owned subsidiary, Lupin Pharmaceuticals, Inc., for infringement of the patents listed in the Orange Book for GLUMETZA® (metformin hydrochloride extended release tablets). | a54473e8vk.htm |
| 2009-11-10 | 8-K | 2009-11-09 | 8.01 Other Events | 8.01 Santarus, Inc. (“Santarus”) was notified by Depomed, Inc. (“Depomed”) that on November 9, 2009 Depomed received a Paragraph IV Certification Notice in accordance with 21 U.S.C. § 355(j)(5)(B) from Lupin Limited (“Lupin”) advising Depomed of the filing of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (the “FDA”) for a generic version of GLUMETZA® (metformin hydrochloride extended release tablets), 500 mg and 1000 mg. | a54302e8vk.htm |
| 2009-11-04 | 8-K | 2009-11-04 | 2.02 Results of Operations and Financial Condition | 2.02 On November 4, 2009, Santarus, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2009. | a54226e8vk.htm |
| 2009-10-13 | 8-K | 2009-10-09 | 1.01 Entry into a Material Definitive Agreement | 1.01 Entry into a Material Definitive Agreement. | a53972e8vk.htm |
| 2009-08-03 | 8-K | 2009-08-03 | 2.02 Results of Operations and Financial Condition | 2.02 On August 3, 2009, Santarus, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2009. | a53320e8vk.htm |
| 2009-07-17 | 8-K | 2009-07-16 | 8.01 Other Events | 8.01 On July 16, 2009, Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware made a partial ruling in favor of Santarus, Inc. (“Santarus”) during a bench trial that began on July 13, 2009. | a53176e8vk.htm |
| 2009-05-06 | 8-K | 2009-05-06 | 2.02 Results of Operations and Financial Condition | 2.02 On May 6, 2009, Santarus, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2009. | a52418e8vk.htm |
| 2009-04-06 | 8-K | 2009-04-06 | 8.01 Other Events | 8.01 On April 6, 2009, Santarus, Inc. (“Santarus”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for a new tablet formulation to add to its Zegerid® family of branded prescription pharmaceutical products. | a52033e8vk.htm |
| 2009-03-05 | 8-K | 2009-03-05 | 2.02 Results of Operations and Financial Condition | 2.02 On March 5, 2009, Santarus, Inc. issued a press release announcing its financial results for the quarter and year ended December 31, 2008. | a51700e8vk.htm |
| 2009-02-24 | 8-K | 2009-02-19 | 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | 5.02 At a meeting held on February 19, 2009, the independent members of the Board of Directors of Santarus, Inc. (the “Company”), based on a recommendation by the Compensation Committee, approved the Santarus, Inc. 2009 Bonus Plan (the “2009 Bonus Plan”). | a51570e8vk.htm |
| 2009-02-19 | 8-K | 2009-02-19 | 2.02 Results of Operations and Financial Condition | 2.02 On February 19, 2009, Santarus, Inc. issued a press release announcing certain preliminary financial results for the year ended December 31, 2008. | a51522e8vk.htm |
| 2009-01-30 | 8-K | 2009-01-30 | 8.01 Other Events | 8.01 On January 30, 2009, Santarus, Inc. (“Santarus”) announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for a new tablet formulation to add to its Zegerid® family of branded prescription pharmaceutical products. | a51201e8vk.htm |
| 2009-01-13 | 8-K | 2009-01-13 | 8.01 Other Events | 8.01 On January 13, 2009, Santarus, Inc. (“Santarus”) announced that Schering-Plough HealthCare Products, Inc. (“Schering-Plough”) had received a Complete Response Letter from the U.S. Food and Drug Administration (“FDA”) for its New Drug Application (“NDA”) seeking approval to sell a Zegerid® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole in the U.S. over-the-counter (“OTC”) heartburn market. | a51052e8vk.htm |