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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
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