Generic Drug Approvals: May 2006
First Time Generic Approvals
- Cefdinir For Oral
Suspension 125 mg/5 mL
Approved: May 31, 2006 Lupin Pharmaceuticals Inc.
Generic for: Omnicef For Oral Suspension, 125 mg/5 mL - Metronidazole
Topical Lotion 0.75%
Approved: May 24, 2006 Altana Inc.
Generic for: Metrolotion Topical Lotion, 0.75% - Escitalopram Oxalate
Tablets 5 mg, 10 mg, and 20 mg
Approved: May 22, 2006 IVAX Pharmaceuticals, Inc.
Generic for: Lexapro Tablets - Cefdinir Capsules, 300
mg
Approved: May 19, 2006 Lupin Limited
Generic for: Omnicef Capsules - Ketotifen
Fumarate Ophthalmic Solution 0.025%
Approved: May 9, 2006 Apotex, Inc.
Generic for: Zaditor Ophthalmic Solution - Colestipol Hydrochloride
For Oral Suspension USP, 5 g Packet or Scoopful
Approved: May 2, 2006 Impax Laboratories, Inc.
Generic for: Colestid
Other Generic Approvals
- Zonisamide Capsules
25 mg, 50 mg, and 100 mg
Approved: May 31, 2006 Invagen Pharmaceuticals, Inc. -
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02
mg; 28-Day Regimen
Approved: May 31, 2006 Watson Laboratories, Inc. - Doxycycline Tablets
50 mg, 75 mg, and 100 mg
Approved: May 31, 2006 Ranbaxy Laboratories Limited - Nystatin Cream
USP, 100,000 Units/gram
Approved: May 31, 2006 Vintage Pharmaceuticals, LLC - Clarithromycin
Tablets USP, 250 mg and 500 mg
Approved: May 31, 2006 Wockhardt Limited - Warfarin Sodium
Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg,
and 10 mg
Approved: May 30, 2006 Zydus Pharmaceuticals USA, Inc. - Cyproheptadine
Hydrochloride Tablets USP, 4 mg
Approved: May 30, 2006 Stason Pharmaceuticals, Inc. - Polyethylene
Glycol 3350 NF Powder For Oral Solution 17 grams/Scoopful
Approved: May 26, 2006 Kali Laboratories, Inc. - Polyethylene
Glycol 3350 NF Powder For Oral Solution 17 grams/Scoopful
Approved: May 24, 2006 Coastal Pharmaceuticals, Inc. - Orphenadrine
Citrate Injection USP, 30 mg/mL; 2 mL vials
Approved: May 24, 2006 Akorn Inc. - Mometasone
Furoate Cream USP, 0.1%
Approved: May 22, 2006 G&W Laboratories, Inc. - Oxycodone
and Acetaminophen Tablets USP, 2.5 mg/400 mg
Approved: May 16, 2006 Mikart Inc. - Ceftriaxone for
Injection USP, 1 gram/vial
Approved: May 12, 2006 Wockhardt Limited - Lorazepam Tablets
USP, 0.5 mg, 1 mg, and 2 mg
Approved: May 10, 2006 Vintage Pharmaceuticals, LLC - Polyethylene
Glycol 3350 NF Powder For Oral Solution 17 g Packet or
Scoopful
Approved: May 4, 2006 Teva Pharmaceuticals USA - Ceftriaxone for
Injection USP, 10 g/vial (Pharmacy Bulk Package)
Approved: May 1, 2006 Teva Pharmaceuticals USA -
Neomycin & Polymyxin B Sulfates & Hydrocortisone Otic
Suspension 3.5 mg (Base)/10,000 U,1%/mL
Approved: May 1, 2006 Pharmaforce, Inc.
