mycin) 250 mg Tablet
Pfizer, Inc.
NDA
50-711
11/02/12
Azithromycin
Zithromax (azithromycin) 600 mg Tablet
Pfizer, Inc.
NDA
50-730
11/02/12
Azithromycin
Zithromax (azithromycin) 500 mg Tablet
Pfizer, Inc.
NDA
50-784
11/02/12
Azithromycin
Zithromax (azithromycin) ER Tablet
Pfizer, Inc.
NDA
50-797
10/11/13
Aztreonam
AZACTAM (aztreonam for injection, USP)
Bristol Myers Squibb Co
NDA
50-580
06/17/13
Aztreonam
AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) for Intravenous Use
Bristol Myers Squibb Co
NDA
50-632
06/17/13
CefaclorCefaclor 500 mg Tablet Extended ReleaseTeva Pharmaceutical USAANDA65-05801/22/15
CefaclorCefaclor Capsules, USP, 250 mg and 500 mgWest-Ward Pharmaceutical Corp.ANDA65-35007/14/15
Caspofungin Acetate
Cancidas (caspofungin acetate) Injection 50 mg/vial & 70 mg/vial
Merck Sharp & Dohme Corp.
NDA
21-227
08/02/13
Cefadroxil
Cefadroxil Tablets, USP, 1000 mg
Teva Pharmaceuticals USA
ANDA
62-774
04/18/12
Cefadroxil hemihydrate Cefadroxil Hemihydrate Oral Suspension Lupin, Ltd. ANDA 65-396 04/18/14
Cefazolin & Dextrose
Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g Intravenous
B.Braun Medical, Inc.
NDA
50-779
04/23/12
Cefazolin
Cefazolin for Injection, USP, Pharmacy Bulk Package bags SmartPak 100g & 300g
Samson Medical Tech, LLC
ANDA
65-141
07/30/13
Cefazolin
Cefazolin for Injection USP, 10 g Pharmacy Bulk
Package
Hospira, Inc.
ANDA
65-247
01/17/13
Cefdinir
OMNICEF (cefdinir) Capsules
Abbott Laboratories
NDA
50-739
06/28/10
Cefdinir
OMNICEF (cefdinir) for Oral Suspension
Abbott Laboratories
NDA
50-749
06/28/10
Cefdinir
Cefdinir Oral Capsules 300 mg
Sandoz, Inc.
ANDA
65-330
09/12/13
Cefdinir
Cefdinir Oral Suspension 125 or 250/5mL
Sandoz, Inc.
ANDA
65-337
09/12/13
Cefditoren Pivoxil
Spectracef (cefditoren pivoxil) 200mg & 400 mg Tablets
Vansen Pharma
NDA
21-222
08/06/12
Cefepime Hydrochloride Maxipime (cefepime hydrochloride, USP) for Injection Hospira, Inc. NDA 50-679 05/01/14
Cefepime Hydrochloride Cefepime (cefepime hydrochloride) Injection Baxter Healthcare Corp. NDA 50-817 06/04/14
Cefepime Cefepime for Injection USP and Dextrose Injection USP in Duplex Container B. Braun Medical, Inc NDA 50-821 06/06/14
Cefixime
Suprax (cefixime) Oral Capsule 400 mg
Lupin Ltd.
NDA
203195
02/20/13
Cefixime
Suprax (cefixime) for Oral Suspension 500 mg/5 mL
Lupin Ltd.
NDA
202091
02/20/13
Cefixime
Suprax (cefixime) Chewable Tablets, 200 mg
Lupin Ltd.
ANDA
65-380
03/29/13
CefobidCefobid (cefoperazone sodium ) IM/IVPfizer, Inc.NDA50-55103/18/15
Cefotaxime sodiumClaforan (cefotaxime sodium) Sterile IV/IMSanofi Aventis US LLCNDA50-54703/03/15
Cefotaxime sodiumClaforan (cefotaxime sodium) InjectionSanofi Aventis US LLCNDA50-59603/03/15
Cefotaxime sodiumCefotaxime Sodium Add Vantage 1g & 2g VialSanofi Aventis US LLCANDA62-65903/03/15
Cefoxitin
Mefoxin (cefoxitin for injection) 1g/10mL, 2g/20mL & 10g/100mL
Mylan Institutional LLC
NDA
50-517
05/10/13
Cefoxitin and Dextrose
Cefoxitin and Dextrose in Duplex Container
B.Braun Medical, Inc.
NDA
65-214
06/05/13
Cefpodoxi |
