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 Safety Information 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… Seroquel (quetiapine fumarate) Tablets AstraZeneca LP NDA 20-639/S011, S004, S006 Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP Seroquel (quetiapine fumarate) Tablets, AstraZeneca, Labeling Revision | Seroquel (quetiapine fumarate) Tablets, AstraZeneca, Manufacturing Change or Addition | Seroquel (quetiapine fumarate) tablets, AztraZeneca Pharma, Labeling Revision | Seroquel (quetiapine) Tablets, AstraZeneca Pharma, New or Modified Indication | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharma, Approval | Seroquel (quetiapine fumarate) Tablets, Astra Zeneca LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Approval | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharma, Labeling Revision | SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Manufacturing Change or Addition | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication| Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca LP, Manufacturing Change or Addition | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Packaging Addition | Quetiapine Fumarate Tablets, Teva Pharmaceuticals USA, Tentative Approval | Quetiapine Fumarate Tablets, Dr. Reddy’s Laboratories Ltd., Tentative Approval | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Efficacy Supp. w/Clinical Data | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Efficacy Supp. and Labeling Revision | Quetiapine Fumarate Extended-Release Tablets, Handa Pharmaceuticals, LLC, Tentative Approval | Quetiapine Fumarate Extended-Release Tablets, Accord Healthcare, Inc., Tentative Approval | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, Labeling Revision | Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision | Quetiapine Fumarate Tablets, Roxane Laboratories, Inc., Tentative Approval | Quetiapine Fumarate Tablets, Roxane Laboratories, Inc., Tentative Approval ^ 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com