First-Time Generic Drug Approvals for 2007
January
- Hydrochlorothiazide Tablets 12.5 mg
Approved: January 23, 2007 - Mylan Pharmaceuticals, Inc.
Generic for: Hydrochlorothiazide Tablets - Fentanyl Transdermal System 12 mcg/hour
Approved: January 23, 2007 - Mylan Technologies, Inc.
Generic for: Duragesic-12 Transdermal System - Propranolol HCl Extended-Release Capsules 60 mg, 80 mg, 120 mg, and 160 mg
Approved: January 26, 2007 - Par Pharmaceuticals, Inc.
Generic for: Inderal LA Capsules - Dexmethylphenidate Hydrochloride Tablets 2.5 mg, 5 mg, and 10 mg
Approved: January 29, 2007 - Teva Pharmaceuticals USA
Generic for: Focalin Tablets - Valacyclovir Hydrochloride Tablets 500 mg (base) and 1 gram (base)
Approved: January 31, 2007 - Ranbaxy Inc.
Generic for: Valtrex Caplets
February
- Sertraline Hydrochloride Tablets 25 mg (base) 50 mg (base), 100 mg (base), 150 mg (base) and 200 mg (base)
Approved: February 6, 2007 - Ranbaxy Laboratories Limited
Generic for: Zoloft Tablets - Ranitidine Oral Solution USP 15 mg/mL
Approved: February 21, 2007 - Actavis Mid Atlantic LLC
Generic for: Zantac Syrup - Rabeprazole Sodium Delayed-Release Tablets 20 mg
Approved: February 21, 2007 - Teva Pharmaceuticals USA
Generic for: Aciphex Delayed-Release Tablets - Citalopram Hydrobromide Capsules 10 mg (base), 20 mg (base), and 40 mg (base)
Approved: February 28, 2007 - Alphapharm Pty. Ltd.
Generic for: Celexa Tablets
March
- Moexipril HCl and Hydrochlorothiazide Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg
Approved: March 7, 2007 - Teva Pharmaceuticals, USA
Generic for: Uniretic Tablets - Didanosine for Oral Solution (Pediatric Powder), 10 mg/mL; 2 gram and 4 gram Containers
Approved: March 8, 2007 - Aurobindo Pharma Limited
Generic for: Videx for Oral Solution - Prednicarbate Ointment 0.1%
Approved: March 9, 2007 - Altana Inc.
Generic for: Dermatop Ointment - Ciprofloxacin Extended-Release Tablets 500 mg and 1000 mg
Approved: March 22, 2007 - Mylan Pharmaceuticals Inc.
Generic for: Cipro XL Tablets - Nadolol and Bendroflumethiazide Tablets USP, 40 mg/5 mg and 80 mg/5 mg
Approved: March 30, 2007 - Impax Laboratories, Inc.
Generic for: Corzide Tablets
April
- Cefixime for Oral Suspension USP, 200 mg/5 mL
Approved: April 10, 2007 - Lupin Limited
Generic for: Cefixime for Oral Suspension - Nimodipine Capsules, 30 mg
Approved: April 17, 2007 - Sun Pharmaceutical Industries, Inc.
Generic for: Nimotop Capsules - Zolpidem Tartrate Tablets 5 mg and 10 mg
Approved: April 23, 2007 - Synthon Pharmaceuticals, Inc.; Apotex Inc.; Ranbaxy Laboratories Limited; Dr. Reddy's Laboratories Ltd.; Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Watson Laboratories, Inc.; Par Pharmaceutical, Inc.; Carlabad Technology, Inc.; Genpharm Inc.; Mutual Pharmaceutical Company, Inc.; Caraco Pharmaceutical Laboratotries, Ltd; Lek Pharmaceuticals, D.D.; Teva Pharmaceuticals USA
Generic for: Ambien Tablets - Pravastatin Sodium Tablets 10 mg, 20 mg, 40 mg, and 80 mg
Approved: April 23, 2007 - Ranbaxy Inc.
Generic for: Pravachol Tablets
May
- Metoprolol Succinate Extended-Release Tablets USP, 50 mg
Approved: May 18, 2007 - Sandoz Inc.
Generic for: Toprol-XL Extended-Release Tablets 50 mg - Metoprolol Succinate Extended-Release Tablets USP, 100 mg and 200 mg
Approved: May 18, 2007 - KV Pharmaceutical Company
Generic for: Toprol-XL Extended-Release Tablets - Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5 mg (base)/10 mg, 5 mg (base)/10 mg, 5 mg (base)/20 mg, and 10 mg (base)/20 mg
Approved: May 18, 2007 - Teva Pharmaceuticals, USA
Generic for: Lotrel Capsules - Betamethasone Dipropionate Lotion USP, (Augmented) 0.05%
Approved: May 21, 2007 - Taro Pharmaceuticals USA, Inc.; Altana Inc.
Generic for: Diprolene Lotion (Augmented)
June
- Benzonatate Capsules USP, 100 mg and 200 mg
Approved: June 8, 2007 - Zydus Pharmaceuticals USA, Inc.
Generic for: Tessalon Capsules (Perles) - Cefepime for Injection USP, 500 mg/vial, 1 gram/vial and 2 grams/vial
Approved: June 18, 2007 - Orchid Healthcare
Generic for: Maxipime For Injection - Tretinoin Capsules 10 mg
Approved: June 21, 2007 - Barr Laboratories, Inc.
Generic for: Vesanoid Capsules, 10 mg - Paroxetine Hydrochloride Extended-Release Tablets, 12.5 mg (base) and 25 mg (base)
Approved: June 29, 2007 - Mylan Pharmaceuticals, Inc.
Generic for: Paxil CR Extended-Release Tablets
July
- Dantrolene Sodium for Injection 20 mg/vial
Approved: July 24, 2007 - US Worldmeds, LLC
Generic for: Dantrium Intravenous 20 mg/vial - Escitalopram Oxalate Capsules 5 mg (base), 10 mg (base) and 20 mg (base)
Approved: July 31, 2007 - Alphapharm Pty. Ltd.
Generic for: Lexapro Tablets
August
- Pantoprazole Sodium Delayed-Release Tablets 20 mg (Base) and 40 mg (Base)
Approved: August 2, 2007 - Teva Pharmaceuticals USA
Generic for: Protonix Delayed-Release Tablets - Fosphenytoin Sodium Injection USP, 75 mg/mL
Approved: August 6, 2007 - Teva Parenteral Medicines, Inc.
Generic for: Cerebyx Injection - Pentostatin For Injection 10 mg/vial
Approved: August 7, 2007 - Bedford Laboratories
Generic for: Nipent Injection - Verapamil Hydrochloride Extended-Release Capsules (PM) 100 mg, 200 mg, and 300 mg
Approved: August 9, 2007 - Mylan Pharmaceuticals, Inc.
Generic for: Verelan PM Extended-Release Capsules - Cefotetan For Injection USP, 1 gram/vial, 2 grams/vial and 10 grams/vial
Approved: August 9, 2007 - Abraxis Pharmaceutical Products
Generic for: Cefotan For Injection - Famciclovir Tablets 125 mg, 250 mg and 500 mg
Approved: August 24, 2007 - Teva Pharmaceuticals USA
Generic for: Famvir Tablets
September
- Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg
Approved: September 5, 2007 - Dr. Reddy's Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Lupin Limited; Caraco Pharmaceutical Laboratories Ltd.; Ranbaxy Laboratories Limited; Glenmark Pharmaceuticals Limited; Teva Pharmaceuticals USA
Generic for: Coreg Tablets - Ciclopirox Topical Solution (Nail Lacquer) 8%
Approved: September 18, 2007 - G & W Laboratories, Inc.; Taro Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis Mid Atlantic LLC; Hi-Tech Pharmacal Co., Inc.; Perrigo Company; Apotex Inc.; Tolmar Inc.; Synerx Pharma, LLC; Teva Pharmaceuticals USA
Generic for: Penlac Nail Lacquer - Hydrocodone Polistirex and Chlorpheniramine Polistirex 5 mg/4 mg and 10 mg/8 mg
Approved: September 24, 2007 - Tyco Healthcare Mallinckrodt
Generic for: Tussinonex Pennkinetic ER Suspension - Albuterol Sulfate Inhalation Solution 0.021% (base) and 0.042% (base)
Approved: September 25, 2007 - Watson Laboratories, Inc.
Generic for: Accuneb Inhalation Solution - Ofloxacin Otic Solution USP, 0.3%
Approved: September 28, 2007 - Apotex Inc.
Generic for: Floxin Otic Solution
October
- Nifedipine Extended-Release Tablets USP, 90 mg
Approved: October 3, 2007 Osmotica Pharmaceutical Corp.
Generic for: Procardia XL Tablets - Risedronate Sodium Tablets 5 mg, 30 mg, and 35 mg
Approved: October 5, 2007 Teva Pharmaceuticals USA
Generic for: Actonel Tablets - Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg
Approved: October 9, 2007 Roxane Laboratories, Inc.; Glenmark Pharmaceuticals, Ltd; Sun Pharmaceutical Industries Ltd.
Generic for: Trileptal Tablets - Hydrocodone Bitartrate and Ibuprofen Tablets 2.5 mg/200 mg (New Strength)
Approved: October 19, 2007 Interpharm Inc.
Generic for: Vicoprofen Tablets - Rivastigmine Tartrate Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base), and 6 mg (base)
Approved: October 22, 2007 Sun Pharmaceutical Industries, Ltd.
Generic for: Exelon Capsules - Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, 1 mg/0.03 mg, 1 mg/0.035 mg (21-Day and 28-Day)
Approved: October 26, 2007 Barr Laboratories, Inc.
Generic for: Estrostep-21 and Estrostep Fe Tablets
November
- Oxycodone Hydrochloride and Ibuprofen Tablets 5 mg/400 mg
Approved: November 26, 2007 Watson Laboratories, Inc.
Generic for: Combunox Tablets
December
- Fomepizole Injection 1 g/mL
Approved: December 14, 2007 Pharmaforce, Inc.
Generic for: Antizol Injection - Extended Phenytoin Sodium Capsules USP 30 mg
Approved: December 18, 2007 Wockhardt Limited
Generic for: Dilantin (Extended Phenytoin Sodium Capsules) - Cetirizine Hydrochloride Tablets (OTC) 5 mg and 10 mg
Approved: December 27, 2007 Mylan Pharmaceuticals, Inc.; Caraco Pharmaceutical Laboratories, Ltd.; Par Pharmaceutical, Inc.; Ranbaxy Laboratories Limited; Sandoz Inc.
Generic for: Zyrtec Allergy Tablets/Zyrtec Hives Relief Tablets - Diclofenac Sodium Ophthalmic Solution 0.1%
Approved: December 28, 2007 Bausch & Lomb Inc.; Nexus Pharmaceuticals, Inc.
Generic for: Voltaren Ophthalmic Solution - Balsalazide Disodium Capsules 750 mg
Approved: December 28, 2007 Roxane Laboratories, Inc.
Generic for: Colazal Capsules - Granisetron Hydrochloride Injection 0.1 mg (base)/1 mL; packaged in 0.1 mg (base)/ 1 mL Single-Use Vials
Approved: December 31, 2007 App Pharmaceuticals, LLC; Watson Laboratories, Inc.
Generic for: Kytril Injection - Granisetron Hydrochloride Injection (Preservative-Free) 1 mg (base)/mL; packaged in 1 mg (base)/1 mL Single-Dose Vials
Approved: December 31, 2007 Teva Parenteral Medicines, Inc.
Generic for: Kytril Injection - Granisetron Hydrochloride Injection 1 mg (base)/mL; packaged in 4 mg (base)/4 mL Multiple-Dose Vials
Approved: December 31, 2007 Baxter Healthcare Corporation
Generic for: Kytril Injection - Granisetron Hydrochloride Tablets 1 mg (base)
Approved: December 31, 2007 Barr Laboratories, Inc.; Teva Pharmaceuticals USA; Corepharma LLC; Roxane Laboratories, Inc.
Generic for: Kytril Tablets