Active Ingredient
Product Name
Company Name
Type of Application
Application Number
Date of Most Recent FDA Review of Microbiology Susceptibility Interpretive Criteria*
Amoxicillin
Amoxil (amoxicillin) Chewable Tablets
Dr. Reddy's Laboratories
NDA
50-542
11/16/11
Amoxicillin
Amoxil (amoxicillin)Tablets-BID
Dr. Reddy's Laboratories
NDA
50-754
11/16/11
Amoxicillin
Amoxicillin Tablets USP, 500 mg & 875 mg
Teva Pharmaceuticals USA
ANDA
65-056
05/02/13
Amoxicillin
Amoxil (amoxicillin) Chewable Tablets BID
Dr. Reddy's Laboratories
NDA
50-761
11/16/11
Amoxicillin
Amoxil (amoxicillin) Oral Suspension - BID
Dr. Reddy's Laboratories
NDA
50-760
11/16/11
Amoxicillin
Amoxicillin for Suspension USP,
200 mg/5 mL and
400 mg/5 mL
Teva Pharmaceuticals USA
ANDA
65-119
11/20/12
Amoxicillin/clavulanate potassium
AUGMENTIN (amox/clavul pot) Tablets 250 & 500 mg
GlaxoSmithKline
NDA
50-564
09/29/11
Amoxicillin/clavulanate potassium
AUGMENTIN (amox/clav pot) Oral Susp 125 & 250 mg/5mL
GlaxoSmithKline
NDA
50-575
09/29/11
Amoxicillin/clavulanate potassium Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5mg per 5 mL & 400 mg/57 mg per 5 mL Teva Pharmaceuticals USA ANDA 65-089 7/25/13
Amoxicillin/clavulanate potassium
AUGMENTIN (amox/clav pot) Chew Tablets 125 & 250 mg
GlaxoSmithKline
NDA
50-597
09/29/11
Amoxicillin/clavulanate potassium Amoxicillin and Clavulanate Potassium Tablets, USP (chewable) 200 mg/28.5mg & 400 mg/57 mg Teva Pharmaceuticals USA ANDA 65-205 07/08/13
Amoxicillin/clavulanate potassium
AUGMENTIN (amox/clav pot) Tablet '875'
GlaxoSmithKline
NDA
50-720
09/29/11
Amoxicillin/clavulanate potassium
AUGMENTIN (amox/clav pot) Oral Susp 200mg/5mL & 400mg/5mL BID
GlaxoSmithKline
NDA
50-725
09/29/11
Amoxicillin/clavulanate potassium
AUGMENTIN (amoxicillin/clavulanate potassium) Chew Tablets 200 & 400 BID
GlaxoSmithKline
NDA
50-726
09/29/11
Amoxicillin/clavulanate potassium
AUGMENTIN ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension
Dr. Reddy's Laboratories
NDA
50-755
08/26/11
Amoxicillin/clavulanate potassium
AUGMENTIN XR (amoxicillin/clavulate potassium) Tablets, 1000mg/62.5mg
Dr. Reddy's Laboratories
NDA
50-785
08/26/11
Ampicillin sodium/sulfactam sodium
Unasyn (ampicillin sodium/sulbactam sodium) for Injection
Pfizer, Inc.
NDA
50-608
03/06/12
Ampicillin sodium/sulfactam sodium Unasyn (ampicillin sodium/sulbactam sodium) for Injection, 2gm/1gm, 1gm/500mg Pfizer, Inc. ANDA 62-901 04/07/14
Ampicillin SodiumAmpicillin for Injection USP, 125mg, 250mg, 500mg, 1g and 2g per vial and 10g Pharmacy Bulk PackageSandoz, Inc.ANDA61-39507/17/15
Amphotericin B
AmBisome (amphotericin B) liposome for Injection
Astellas Pharma U.S. Inc.
NDA
50-740
03/08/12
Azithromycin
Zithromax (azithromycin for injection) IV
Pfizer, Inc.
NDA
50-733
11/16/11
Azithromycin
Zithromax (azithromycin for oral suspension) Single-Dose Packet
Pfizer, Inc.
NDA
50-693
11/02/12
Azithromycin
Zithromax (azithromycin for oral suspension)
Pfizer, Inc.
NDA
50-710
11/02/12
Azithromycin
Zithromax (azithro |
