-
April 2013
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 205569).
-
March 2013
- Sigmapharm launches, exclusively under its own label, its 9th generic product, Sodium Phenylbutyrate Powder in 250-g-fill Bottles, which is the first-and-only approved generic equivalent to BUPHENYL® Powder.
- Sigmapharm receives FDA approval for generic Sodium Phenylbutyrate Powder in 250-g-fill Bottles, based on its ANDA No. 202819.
-
December 2012
Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 8th generic product, Griseofulvin Tablets, USP (microsize) 500 mg, which is the first-and-only approved generic equivalent to GRIFULVIN-V® Tablets.
-
November 2012
- Sigmapharm launches its 7th generic product, Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, exclusively under its own label. This is the company’s 1st generic product marketed solely under Sigmapharm’s own label.
- Sigmapharm receives FDA approval for generic Liothyronine Sodium Tablets, USP 5 mcg, 25 mcg and 50 mcg, based on its ANDA No. 200295.
- Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 6th generic product, Utramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, which is the first-and-only approved generic equivalent to GRIS-PEG® Tablets.
-
October 2012
- Sigmapharm receives FDA approval for generic Griseofulvin Tablets, USP (microsize) 500 mg, based on its ANDA No. 202482.
- Sigmapharm receives FDA approval for generic Utramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, based on its ANDA No. 202545.
-
August 2012
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 204633).
-
December 2011
Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 202819.
-
November 2011
Sigmapharm launches, through Rising Pharmaceuticals, Inc., its 5th generic product, Flucytosine Capsules, USP 250 mg and 500 mg, which is the first-and-only approved generic equivalent to ANCOBON® Capsules.
-
June 2011
Sigmapharm receives FDA approval for generic Flucytosine Capsules, USP 250 mg and 500 mg, based on its ANDA No. 201566.
-
May 2011
Sigmapharm successfully completes an FDA inspection focused on its current GMP status and a Pre-Approval-Inspection related to its ANDA No. 202051.