NDA
50-795
04/11/13
Doxycycline hyclate Doxycycline Hyclate Tablets, USP 100 mg West-Ward Pharmaceutical Corp ANDA 65-095 06/25/14
Ertapenem sodium
Invanz (ertapenem sodium)
Merck, Sharp & Dohme
NDA
21-337
02/17/12
Erythromycin
ERYC (erythromycin delayed release capsules, USP) 250 mg
Mayne Pharma International
NDA
50-536
03/21/13
Erythromycin
Erythromycin Tablets USP, 250 mg and 500 mg
Arbor Pharmaceuticals, Inc.
ANDA
61-621
12/04/13
Erythromycin
ERY-TAB (erythromycin delayed-release tablets, USP) Enteric-Coated, 250
mg, 333 mg, and 500 mg.
Arbor Pharmaceuticals, Inc.
ANDA
62-298
12/04/13
Erythromycin ethylsuccinate
E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) EryPed 200, 400, & drops
Abbott Laboratories
NDA
50-207
11/04/10
Erythromycin ethylsuccinate
Ery-Ped Chewable Tablets (erythromycin ethylsuccinate, USP)
Abbott Laboratories
NDA
50-297
11/04/10
Erythromycin ethylsuccinate
EES (erythromycin ethylsuccinate oral suspension, USP)
Liquid 200 mg/5 mL and 400 mg/5 mL
Arbor Pharmaceuticals, Inc.
ANDA
61-639
10/31/13
Erythromycin ethylsuccinate
Erythromycin Ethylsuccinate Tablets USP, 400 mg.
Arbor Pharmaceuticals, Inc.
ANDA
61-904
12/04/13
Erythromycin ethylsuccinate
EES 400 Film-coated Tablets (erythromycin ethylsuccinate tablets, USP) 400 mg
Arbor Pharmaceuticals, Inc.
ANDA
61-905
10/31/13
Erythromycin lactobionate
Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) vials
Hospira, Inc.
NDA
50-609
06/09/11
Erythromycin lactobionate
Erythromycin Lactobionate I.V. (erythromycin lactobioinate for injection, USP) 500 mg and 1 g ADD-Vantage Vials
Hospira, Inc.
ANDA
62-638
08/26/13
Erythromycin particles
PCE Tablets (erythromycin particles in tablets) Dispertab Tablets
Abbott Laboratories
NDA
50-611
11/04/10
Erythromycin stearate
Erythrocin Stearate (erythromycin stearate tablets, USP) Film-coated Tablets, 250 mg
Arbor Pharmaceuticals, Inc.
ANDA
60-359
12/04/13
Fosfomycin tromethamine
Monurol (fosfomycin tromethamine) Sachet
Forest Laboratories, Inc.
NDA
50-717
03/15/10
Gemifloxacin mesylate
Factive (gemifloxacin mesylate) Tablet
Cornerstone Therapeutics, Inc.
NDA
21-158
10/18/11
Gentamicin Sulfate Gentamicin Sulfate Injection Fresenius Kabi USA, LLC ANDA 62-366 03/07/14
Imipenem and Cilastatin
Primaxin I.V. (imipenem and cilastatin for injection)
Merck, Sharp & Dohme
NDA
50-587
04/16/12
Kanamycin InjectionKanamycin Injection USP,
1 gm per 3 mLFresenius Kabi, USA, LLCANDA65-11107/15/15
Levofloxacin
Levaquin (levofloxacin) Tablet
Johnson & Johnson
NDA
20-634
06/10/11
Levofloxacin
Levaquin (levofloxacin) Injection
Johnson & Johnson
NDA
20-635
06/09/11
Levofloxacin
Levaquin (levofloxacin) Oral Solution
Johnson & Johnson
NDA
21-721
06/09/11
Lincomycin hydrochloride Lincocin (lincomycin hydrochloride Injection, USP) Sterile Solution Pfizer Inc. NDA 50-317 10/15/14
Linezolid
Zyvox (linezolid) Tablets
Pfizer Inc.
NDA
21-130
06/05/15
Linezolid
Zyvox (linezolid) IV Injection
Pfizer Inc.
NDA
21-131
06/05/15
Linezolid
Zyvox (linezolid) Oral Suspension
Pfizer Inc.
NDA
21-132
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