Bayer Healthcare Pharmaceuticals
NDA
19-537
01/30/13
Ciprofloxacin HCl
Cipro I.V. (ciprofloxacin hydrochloride) 1% Solution in Vials
Bayer Healthcare Pharmaceuticals
NDA
19-847
01/30/13
Ciprofloxacin HCl
Cipro (ciprofloxacin hydrochloride) Solution in 5% Dextrose
Bayer Healthcare Pharmaceuticals
NDA
19-857
01/30/13
Ciprofloxacin HCl
Cipro (ciprofloxacin HCl) 5% and 10% Oral Suspension
Bayer Healthcare Pharmaceuticals
NDA
20-780
01/30/13
Ciprofloxacin HCl
Cipro XR (ciprofloxacin HCl) Tablets
Bayer Healthcare Pharmaceuticals
NDA
21-473
01/30/15
Ciprofloxacin HCl Ciprofloxacin Extended Release Tablets 500 mg and 1000 mg Mylan Pharms Inc. ANDA 78-183 8/14/13
Ciprofloxacin HCl
Proquin XR (ciprofloxacin hydrochloride)
Depomed, Inc.
NDA
21-744
12/29/10
Clarithromycin
BIAXIN Filmtabs (clarithromycin tablets, USP)
Abbott Laboratories
NDA
50-662
05/03/12
Clarithromycin
BIAXIN Granules (clarithromycin for oral suspension, USP)
Abbott Laboratories
NDA
50-698
05/03/12
Clarithromycin
BIAXIN XL Filmtabs (clarithromycin ER tablets)
Abbott Laboratories
NDA
50-775
05/03/12
Clindamycin hydrochloride
Cleocin HCl (clindamycin hydrochloride) 75mg, 150 mg, 300 mg capsules
Pfizer, Inc.
NDA
50-162
06/07/11
Clindamycin phosphate and dextrose
Cleocin Phosphate (clindamycin phosphate with 5% dextrose) injection
Pfizer, Inc.
NDA
50-639
06/07/11
Clindamycin phosphate
Cleocin Phosphate (clindamycin phosphate, USP) Injection
Pfizer, Inc.
NDA
50-441
06/07/11
Dalbavancin Hydrochloride Dalvance (dalbavancin) for Injection, for intravenous use Durata Therapeutics, Inc. NDA 21-883 05/23/14
Daptomycin
Cubicin (daptomycin for injection)
Cubist Pharmaceuticals
NDA
21-572
10/03/11
Demeclocycline hydrochloride
Declomycin (demeclocycline hydrochloride) Tablets
CorePharm LLC
NDA
50-261
09/05/12
Demeclocycline hydrochloride Demeclocycline hydrochloride Tablets USP, 150 mg and 300 mg Amneal Pharm ANDA 65-425 02/05/13
Doripenem
DORIBAX (doripenem for injection)
Janssen Research and Development LLC
NDA
22-106
01/26/12
Doxycycline
DOXY 100 & 200TM (Doxycycline for Injection USP, 100 mg and 200 mg
per vial).
Fresenius Kabi USA, LLC
ANDA
62-475
01/28/14
Doxycycline Doxycycline Capsules USP, 50 mg, 75 mg, 100 mg, and 150 mg Par Pharmaceuticals, Inc. ANDA 65-055 07/10/14
Doxycycline
Doxycycline Capsules USP, 50 mg, 75 mg, 100 mg, and 150 mg
Par Pharmaceutical, Inc.
ANDA
65-055
12/14/12
Doxycycline monohydrate
Monodox (doxycycline monohydrate) Capsules
Watson Laboratories, Inc.
NDA
50-641
01/11/12
Doxycycline monohydrate
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension
Pfizer, Inc.
NDA
50-006
04/29/13
Doxycycline hyclate
Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capules
Pfizer, Inc.
NDA
50-007
04/29/13
Doxycycline calcium
Vibramycin Calcium (doxycycline calcium oral suspension, USP) Syrup
Pfizer, Inc.
NDA
50-480
04/29/13
Doxycycline hyclate
Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets
Pfizer, Inc.
NDA
50-533
04/29/13
Doxycycline hyclate
Doryx (doxycycline hyclate delayed release tablets) Tablets 80, 100, 150 & 200 mg
Mayne Pharma International
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