Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com