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FDA Approval Activities for this Drug…
Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Takeda NDA 21-073/S-021 6/11/03 7/8/03 7/8/03 Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Takeda NDA 21-073/S-017 1/17/03 1/23/03 Actos (pioglitazone HCl) Tablets, Takeda NDA 21-073/S16 1/7/02 2/8/02 Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Takeda North America, Inc NDA 21-073/S-018 12/3/02 12/9/02 Actos (pioglitazone) Tablets, Takeda NDA 21-073/S10 7/12/02 7/15/02 7/15/02 Actos (or pioglitazone HCl) oral Tablets, 15 mg, 30 mg, and 45 mg, Takeda NDA 21-073 7/15/99 7/28/99 7/28/99 6/30/00 Actos Indicated: for the improvement of glycemic control in patients with Type 2 diabetes as monotherapy, or in combination with a sulfonylurea, metformin or insulin when diet and the single agent does not result in adequate glycemic control. Actos (pioglitazone HCl) Tablets, Takeda Actos (pioglitazone HCl) Tablets, Takeda, Labeling Revision Actos (pioglitazone HCl) Tablets, Takeda Global, Labeling Revision | Pioglitazone Hydrochloride Tablets, Mylan Pharma, Tentative Approval | Pioglitazone Hydrochloride Tablets, Alphapharm, Tentative Approval | Actoplus Met (pioglitazone and metformin HCl) Tablets, Takeda Global, Approval | Pioglitazone Hydrochloride Tablet, Watson Labs, Tentative Approval | Pioglitazone Hydrochloride Tablets, Teva Pharma, Tentative Approval | Duetact (Pioglitazone HCI, Glimepiride) Combination Tablets, Takeda Global, Approval | Actos Tablet, Takeda Pharmaceuticals, Labeling Revision | Actoplus MET Tablet, Takeda Pharmaceuticals, Labeling Revision | Actos (pioglitazone HCl), Takeda Global, Labeling Revision | ActoPlus Met (pioglitazone HCl plus metformin HCl) Global, Labeling Revision | Actos (pioglitazone HCl) tablets, Takeda Global, Labeling Revision | Actoplus Met (pioglitazone HCl + metformin HCl) fixed-dose combination tablets, Takeda Global, Labeling Revision | DUETACT (pioglitazone HCl + glimepiride) fixed-dose combination tablets, Takeda Global, Labeling Revision | Actos (pioglitazone HCl) Tablets, Takeda Global, Efficacy Supp. w/Clinical Data | Actos (pioglitazone HCl) Tablets, Takeda Global, Labeling Revision | Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets, Takeda Global, Package ChangeActos (pioglitazone HCl) Tablets, Takeda Global Research, Labeling Revision | Actoplus Met (pioglitazone HCl and metformin HCl) fixed-dose combination Tablets, Takeda Global, Labeling Revision | DUETACT (pioglitazone HCl plus glimepiride) fixed-dose combination Tablets, Takeda Global, Labeling Revision | Duetact (pioglitazone HCl plus glimepiride) Fixed-dose Combination Tablets, Takeda Global, Formulation Revision | Actos (pioglitazone hydrochloride), Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actos (pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | ActoPlus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets, Takeda Global Research & Development Center, Inc., Approval | Actos (pioglitazone hydroclhloride) Tablets, Takeda Global Research & Development Center, Inc., Supplement | Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Supplement | Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Supplement | Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actos (pioglitazone hydrochloride) Tablets, Takeda Pharmaceuticals, Labeling Revision | Actoplus Met (pioglitazone hydrochloride plus metformin hydrochloride) Tablets, Takeda Pharmaceuticals, Labeling Revision | Duetact (glimepiride and pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actos (pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) Extended-Release Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Actos (pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  
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