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April 2011
Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 4th generic product, Disulfiram Tablets, USP 250 mg, which is the first-and-only approved generic equivalent to ANTABUSE® Tablets.
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January 2011
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202819).
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November 2010
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202545).
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October 2010
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202482).
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September 2010
Gilead Sciences, Inc., sues Sigmapharm Laboratories, LLC, to challenge the approval of Sigmapharm’s Adefovir Dipivoxil Tablets proposed as the generic equivalent of Gilead’s HEPSERA® Tablets.
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July 2010
- Sigmapharm launches its 3rd generic product, Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), for commercial marketing through Rising Pharmaceuticals, Inc.
- Sigmapharm receives FDA approval for generic Ergocalciferol Capsules, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), based on its ANDA No. 091004.
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June 2010
- Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 2nd generic product, Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, which is the second approved generic equivalent to VIVACTIL® Tablets.
- Sigmapharm files an Abbreviated New Drug Application (ANDA No. 202051), which contains a Paragraph-IV certification. This is our 1st Paragraph-IV filing.
- Sigmapharm files a Drug Master File for Amorphous Adefovir Dipivoxil (DMF No. 023844). This is our 1st DMF submission.
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May 2010
Sigmapharm receives FDA approval for generic Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, based on its ANDA No. 090462.
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March 2010
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 201566).