|
|
|
 |
FDA Approval Activities for this Drug…
Arthrotec (Diclofenac Sodium/Misoprostol) Tablets G.D. Searle& Co. NDA 20-607/S004 Diclofenac Potassium Tablets, 50 mg, Eon Labs manufacturing, ANDA 75-582 2/23/01 3/6/01 Diclofenac Potassium Tablets, 50 mg, Mutual Pharmaceutical Co., ANDA 75-470 2/21/02 Diclofenac Potassium Tablets, 50 mg, Mylan ANDA 75-463 7/26/99 7/29/99 Diclofenac Potassium Tablets, 50 mg, Invamed ANDA 75-229 11/25/98 11/200/98 Diclofenac Potassium Tablets, 50 mg, Teva USA ANDA 75-219 8/6/98 8/7/98 Diclofenac Potassium Tablets, 50 mg, Watson, ANDA 75-152 11/27/98 12/1/98 Diclofenac Sodium Delayed-release Tablets USP, 50 & 75 mg, Alphapharm Pty. Ltd. ANDA 75-281 2/12/02 Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg, 75 mg, Carlsbad Technology ANDA 75-185 11/13/98 11/16/98 Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg, 75 mg, Martec Scientific ANDA 74-986 2/26/99 3/4/99 8/23/01 Diclofenac Sodium Delayed-release Tablets USP, 50 mg & 75 mg Sidmak ANDA 74-432 7/29/99 8/4/99 Diclofenac Sodium Delayed-release Tablets USP, 50 mg, Novopharm Ltd. ANDA 74-723 3/30/99 4/1/99 Diclofenac Sodium extended-release Tablets USP, 100 mg, Mylan ANDA 76-152 12/13/01 Diclofenac Sodium extended-release Tablets USP, 100 mg, Purepac Pharmaceutical Co. ANDA 75-910 1/7/00 Diclofenac Sodium extended-release Tablets USP, 100 mg, Keller & Heckman ANDA 75-492 2/11/00 2/17/00 6/7/01 Diclofenac Sodium Ophthalmic Solution, 0.1%, Alcon NDA 20-809 5/4/98 1/6/99 1/8/99 3/14/00 Diclofenance Indication:treatment of postoperative inflammation in patients who have undergone cataract extraction. Solaraze (diclofenac sodium) Gel, Bioglan Pharmaceutical NDA 21-005/S6 4/29/03 Solaraze (diclofenac sodium) Gel,Rx SkyePharma NDA 21-005 10/16/00 10/20/00 10/20/00 7/8/03 Solaraze Indications: actinic keratoses (AK) Voltaren (diclofenac sodium) Tablets, 25, 50, and 75 mg., Ciba NDA 19-201/S-018 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Eon 075229 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Geneva TECH 075470 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Mutual 075463 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Mylan 020142 DICLOFENAC POTASSIUM Tablet; 50MG CATAFLAM NOVARTIS 075219 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Teva 075152 DICLOFENAC POTASSIUM Tablet; 50MG DICLOFENAC POTASSIUM Watson 021005 DICLOFENAC SODIUM Gel; Topical 3% SOLARAZE BIOGLAN 020037 DICLOFENAC SODIUM Solution/Drops; Ophthalmic 0.1% VOLTAREN NOVARTIS 075281 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Alphapharm 075281 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Alphapharm 075185 DICLOFENAC SODIUM Tablet, Delayed Release; 25MG DICLOFENAC SODIUM CARLSBAD 075185 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM CARLSBAD 075185 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM CARLSBAD 074459 DICLOFENAC SODIUM Tablet, Delayed Release; 25MG DICLOFENAC SODIUM Copley 074459 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Copley 074459 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Copley 074376 DICLOFENAC SODIUM Tablet, Delayed Release; 25MG DICLOFENAC SODIUM Geneva 074376 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Geneva 074394 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Geneva 074986 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Martec 074986 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Martec 019201 DICLOFENAC SODIUM Tablet, Delayed Release; 25MG VOLTAREN NOVARTIS 019201 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG VOLTAREN NOVARTIS 019201 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG VOLTAREN NOVARTIS 074432 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Pliva 074432 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Pliva 074514 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Purepac 074514 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Purepac 074391 DICLOFENAC SODIUM Tablet, Delayed Release; 25MG DICLOFENAC SODIUM Roxane 074391 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Roxane 074391 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Roxane 074723 DICLOFENAC SODIUM Tablet, Delayed Release; 50MG DICLOFENAC SODIUM Teva 074390 DICLOFENAC SODIUM Tablet, Delayed Release; 75MG DICLOFENAC SODIUM Teva 075492 DICLOFENAC SODIUM Tablet, Extended Release; 100MG DICLOFENAC SODIUM BIOVAIL 076201 DICLOFENAC SODIUM Tablet, Extended Release; 100MG DICLOFENAC SODIUM DEXCEL LTD 076152 DICLOFENAC SODIUM Tablet, Extended Release; 100MG DICLOFENAC SODIUM Mylan 020254 DICLOFENAC SODIUM Tablet, Extended Release; 100MG VOLTAREN-XR NOVARTIS 075910 DICLOFENAC SODIUM Tablet, Extended Release; 100MG DICLOFENAC SODIUM Purepac 020607 DICLOFENAC SODIUM; MISOPROSTOL Tablet, Delayed Release; 50MG;0.2MG ARTHROTEC GD SEARLE 020607 DICLOFENAC SODIUM; MISOPROSTOL Tablet, Delayed Release; 75MG;0.2MG ARTHROTEC GD SEARLE Diclofenac Potassium Tablets, TorPharm, Inc. Solaraze (diclofenac sodium) Gel, Bioglan Pharmaceutical Solaraze (Diclofenac Sodium) Gel, Bioglan Pharma, Package Change | Arthrotec (diclofenac sodium), Pfizer, Labeling Revision | Cataflam (diclofenac potassium) Tablets, Novartis Pharma, Labeling Revision | Voltaren (diclofenac sodium) Enteric-coated Tablets, Novartis Pharma, Labeling Revision | Voltaren-XR (diclofenac sodium) Tablets, Novartis Pharma, Labeling Revision | Diclofenac Sodium Ophthalmic Solution, Apotex Inc., Tentative Approval | Diclofenac Sodium Opthalmic Solution, Akorn Inc., Tentative Approval | Flector Patch (diclofenac epolamine topical patch), Institut Biochique, Approval | Solaraze (diclofenac sodium) Gel, Bradley Pharma, Manufacturing Change or Addition | Diclofenac Sodium Delayed-Release Tablets, Dr. Reddy’s Labs, Approval | Voltaren (diclofenac sodium) Enteric-coated Tablets, Novartis Pharma, Labeling Revision | Arthrotec (diclofenac sodium and misoprostol) Tablets, Pfizer, Inc., Labeling Revision | Voltaren (diclofenac sodium) Ophthalmic Solution, Novartis Pharma, Labeling Revision | Voltaren Gel (diclofenac sodium) Topical Gel, Novartis, Approval | Diclofenac Sodium Ophthalmic Solution, Bausch & Lomb, Approval | Diclofenac Sodium Ophthalmic Solution, Nexus Pharma, Approval | Diclofenac Sodium Ophthalmic Solution, Alcon Research, Approval | Diclofenac Sodium Ophthalmic Solution, Akorn Inc., Approval | Flector (diclofenac epolamine) Patch, Institute Biochimique SA (IBSA), Labeling Revision | Flector (diclofenac epolamine) Patch, Institut Biochimique SA (IBSA), Labeling Revision | Diclofenac Sodium Ophthalmic Solution, Apotex, Approval
|