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VENLAFAXINE

 
 

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FDA Approval Activities for this Drug…

Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Capsules, Wyeth-Ayerst NDA 20-151/S16, S19, S20, S21, S22, S23, S25 & 20-699/S14, S18, S21, S23, S26, S27, S34 1/31/03 2/12/03 | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, 37.5 mg, 75 mg, and 150 mg, Wyeth-Ayerst NDA 20-699/S-015, S016, 20-151/S017, S018 5/2/01 7/30/03 4/25/03 | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, 37.5 mg, 75 mg, and 150 mg, Wyeth-Ayerst NDA 20-699/S-032 2/26/03 3/10/03 | Effexor, Wyeth-Ayerst NDA 20-151/S17 & S18 5/2/01 4/23/03 | Effexor XR, Wyeth-Ayerst NDA 20-151/S15 & S16 5/2/01 | Effexor Indications: Prevention o relapse and recurrence of depression. | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth-Ayerst NDA 20-699/S-022 2/11/03 2/12/03 2/13/03 | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth-Ayerst NDA 20-699/S-029 10/22/02 10/28/02 | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules. Wyeth-Ayerst Research NDA 20-699/S-001 3/11/99 3/22/99 3/22/99 | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules. Wyeth-Ayerst Research NDA 20-699/S-038 & S-043 Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharmaceuticals Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Tablets & Capsules, Wyeth Pharmaceuticals Effexor & Effexor XR (Venlafaxine Hydrochloride) Immediate & Extended Release Tablets & Capsules,Wyeth Pharmaceuticals Effexor, Wyeth Pharmaceuticals, Inc., NDA 020699S030 Effexor (venlafaxine hydrochloride) Immediate Release Tablets & Extended Release Capsules, Wyeth Pharmaceuticals | Effexor (venlafaxine hydrochloride) Immediate Release, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine HCL) Extended-Release Capsules, Wyeth Pharma, Patient Population Altered | Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor XR Extended Release capsule, Wyeth Pharma, Package Change | Venlafaxine Hydrochloride Tablets, Teva Pharma, Approval | Venlafaxine Hydrochloride Tablets, Mylan Pharma, Approval | Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor (venlafaxine hydrochloride) Immediate Release Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Venlafaxine Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval | Venlafaxine Hydrochloride Tablets, Zydus Pharma, Tentative Approval | Venlafaxine Hydrochloride Tablets, Sandoz Inc., Tentative Approval | Venlafaxine Hydrochloride Tablets, Pliva Hrvatska, Tentative Approval | Effexor (venlafaxine HCl) Tablets, Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, Labeling Revision | Venlafaxine Hydrochloride Extended-Release Capsules, Impax Labs, Tentative Approval | Effexor XR (venlafaxine HCl) Extended-Release Capsules, Wyeth Pharma, New Modified Indication | Effexor XR (venlafaxine HCl) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor (venlafaxine HCl) Tablet, , Wyeth Pharma, Labeling Revision | Effexor XR (venlafaxine HCl) Extended Release Capsules, Wyeth Pharma, Labeling Revision | Effexor (venlafaxine HCl) Immediate Release, Wyeth Pharma, Labeling Revision | Venlafaxine Hydrochloride Extended-Release Tablets, Osmotica Pharmaceutical Corp., Approval | Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision | Venlafaxine Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval | Venlafaxine Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval | Venlafaxine Hydrochloride Tablets, Pliva Hrvatska, Approval | Venlafaxine Hydrochloride Tablets, Sandoz, Inc., Approval | Venlafaxine Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals Inc., Tentative Approval | Venlafaxine Hydrochloride Tablets, Actavis Totowa LLC, Approval | Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision | Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision | Venlafaxine Hydrochloride Extended-Release Tablets, Osmotica Pharmaceutical Corp., Labeling Revision | Venlafaxine Hydrochloride Extended Release Tablets, Osmotica Pharmaceutical Corp., Package Change | Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Labeling Revision | Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision | Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules, Wyeth Pharmaceuticals, Inc., Labeling Revision | Venlafaxine Hydrochloride Tablets, Auroblndo Pharma Limited, Approval | Venlafaxine Hydrochloride Tablets, Amneal Pharmaceuticals, Approval| Venlafaxine Hydrochloride Tablets, Vintage Pharmaceuticals, Approval | Venlafaxine Hydrochloride Extended-Release Tablets, Sun Pharmaceutical Industries, Inc., Approval | Venlafaxine Hydrochloride Tablets, Alembic, Ltd., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Aurobindo Pharma, Ltd., Tentative Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Aurobindo Pharma, Ltd., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Zydus Pharmaceuticals USA, Inc., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Biovail Laboratories Int'l., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Torrent Pharmaceuticals Ltd., Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Orchid Healthcare, Approval | Venlafaxine Hydrochloride Extended-Release Capsules, Orchid Healthcare, Approval

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