Generic Drug Approvals: September 2006
First Time Generic Approvals
- Famotidine Tablets
USP, (OTC) 20 mg
Approved: September 25, 2006 Perrigo R&D Company, Dr Reddy’s Laboratories Limited
Generic for: Pepcid AC Tablets 20 mg - Caffeine Citrate
Oral Solution USP, 20 mg/mL; 3 mL vials
Approved: September 21, 2006 Pharmaforce Inc.
Generic for: Cafcit Oral Solution - Caffeine Citrate
Injection USP, 20 mg/mL; 3 mL single-dose vials
Approved: September 21, 2006 Pharmaforce Inc.
Generic for: Cafcit Injection - Prednicarbate
Cream, 0.1% (Emollient) 0.1%
Approved: September 19, 2006 Altana Inc.
Generic for: Dermatop Emollient Cream, 0.1% - Diltiazem Hydrochloride
Extended-Release Capsules USP, (once-a-day dosage) 120 mg, 180
mg, 240 mg, 300 mg, 360 mg, and 420 mg
Approved: September 12, 2006 K V Pharmaceutical Company
Generic for: Tiazac Extended-Release Capsules - Topiramate Tablets
25 mg, 100 mg, and 200 mg
Approved: September 11, 2006 Mylan Pharmaceuticals, Inc.
Generic for: Topamax Tablets -
Loperamide Hydrochloride and Simethicone Tablets, (OTC) 2
mg/125 mg
Approved: September 6, 2006 Ranbaxy Laboratories Limited
Generic for: Imodium Advanced Caplets (OTC) -
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03
mg
Approved: September 6, 2006 Watson Laboratories, Inc.
Generic for: Seasonale Tablets, 0.15 mg/0.03 mg
Other Generic Approvals
- Zonisamide Capsules
25 mg and 50 mg
Approved: September 29, 2006 Dr. Reddy’s Laboratories Limited - Carboplatin
Injection 10 mg/mL; 5 mL, 15 mL, and 45 mL multiple-dose
vials
Approved: September 29, 2006 Dabur Oncology plc - Oxycodone
Hydrochloride and Acetaminophen Oral Solution 5 mg/325 mg per 5
mL
Approved: September 29, 2006 Tyco Healthcare Mallinckrodt - Lisinopril
and Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg,
and 20 mg/25 mg
Approved: September 27, 2006 Lupin Limited - Polyethylene
Glycol 3350 NF Powder For Oral Solution 17 grams/scoopful
Approved: September 27, 2006 YVR Therapeutics, LLC - Naproxen
Sodium & Pseudoephedrine HCl Extended-Release Tablets 220
mg/120 mg; (OTC)
Approved: September 27, 2006 Dr. Reddy’s Laboratories Limited - Bupivacaine HCl &
Epinephrine Injection USP, 0.5%/1:200,000; Packaged In 1.8 mL
cartridges
Approved: September 27, 2006 Septodont Inc. -
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets
712.8 mg/60 mg/32 mg
Approved: September 22, 2006 West-Ward Pharmaceutical Corp. - Furosemide Tablets
USP, 20 mg, 40 mg, and 80 mg
Approved: September 18, 2006 OHM Laboratories, Inc. - Cefadroxil Capsules
USP, 500 mg and 1 gram
Approved: September 18, 2006 Orchid Healthcare - Azithromycin for Oral
Suspension USP, 100 mg/5 mL and 200 mg/5 mL
Approved: September 18, 2006 Sandoz Inc. - Gabapentin Tablets
600 mg and 800 mg
Approved: September 13, 2006 Apotex Inc. - Atenolol Tablets USP,
25 mg, 50 mg, and 100 mg
Approved: September 13, 2006 Unique Pharmaceutical Laboratories - Phenytoin
Sodium Injection USP, 50 mg/mL; 2 mL and 5 mL vials
Approved: September 13, 2006 Hikma Farmaceutica (Portugal), S.A. - Midodrine Hydrochloride
Tablets 2.5 mg, 5 mg, and 10 mg
Approved: September 12, 2006 Apotex Corp. - Ceftriaxone
for Injection USP, 10 grams/vial; (Pharmacy Bulk Package)
Approved: September 12, 2006 Lupin Limited - Halobetasol
Propionate Ointment 0.05%
Approved: September 7, 2006 G & W Laboratories, Inc. - Extended Phenytoin Sodium
Capsules USP 100 mg
Approved: September 5, 2006 Taro Pharmaceutical Industries, Ltd.
