Abbreviated
|
|
Product
|
Sponsor
|
Date
Approved
(Application No.)
|
|
Amoxicillin
USP, 875 mg tabs.
|
Hikma
|
3/29/2006
(65-255)
|
|
Benazepril
hydrochloride 5 mg, 10 mg, 20 mg and 40 mg
tabs.
|
Apotex
|
3/8/2006
(77-128)
|
|
Brimonidine
tartrate ophthalmic solution 0.2%
|
Akorn
|
3/14/2006
(76-439)
|
|
Calcitrol
0.25 mcg caps.
|
Roxane
|
3/27/2006
(76-917)
|
|
Cefadroxil
USP, 1 gram tabs.
|
West-Ward
|
3/30/2006
(65-260)
|
|
Cefoxitin
for injection USP, 1 g/50 mL and 2 g/50 mL; packaged
in the duplex drug delivery system
|
B.
Braun
|
3/10/2006
(65-214)
|
|
Cefuroxime
axetil USP, 125 mg (base), 250 mg (base) and 500 mg
(base) tabs.
|
Aurobindo
|
3/29/2006
(65-308)
|
|
Ciclopirox
olamine cream USP, 0.77%
|
Perrigo
|
3/3/2006
(77-364)
|
|
Cilostazol
50 mg and 100 mg tabs.
|
Mutual
|
3/29/2006
(77-208)
|
|
Citalopram
hydrobromide 10 mg (base), 20 mg (base) and 40 mg
(base) tabs.
|
Taro
|
3/22/2006
(77-278)
|
|
Desmopressin acetate 0.1 mg and 0.2 mg
tabs.
|
Apotex
|
3/7/2006
(77-414)
|
|
Fluticasone
propionate ointment, 0.005%
|
G &
W
|
3/3/2006
(77-168)
|
|
Lisinopril
and hydrochlorothiazide 10 mg/12.5 mg, 20 mg/12.5 mg
and 20 mg/25 mg tabs.
|
Aurobindo
|
3/14/2006
(77-606)
|
|
Lorazepam
USP, 0.5 mg, 1 mg and 2 mg tabs.
|
Mylan
|
3/16/2006
(77-657)
|
|
Mometasone
furoate topical solution USP, 0.1% (lotion)
|
Taro
|
3/15/2006
(76-788)
|
|
Propofol
injectable emulsion 1% (10 mg/mL); packaged in 200
mg/20 mL single-dose vials, and 500 mg/50 mL &
1,000 mg/100 mL single-patient infusion vials
|
Hospira
|
3/17/2006
(77-908)
|
|
Terconazole
vaginal suppositories 80 mg
|
Perrigo
|
3/17/2006
(77-149)
|
|
Zidovudine
USP, 100 mg caps.
|
Aurobindo
|
3/27/2006
(78-128)
|
|
Zonisamide
25 mg, 50 mg and 100 mg caps.
|
Sun
|
3/17/2006
(77-634)
|
|
Tentative Abbreviated
|
|
Carvedilol
3.125 mg, 6.25 mg, 12.5 mg and 25 mg tabs.
|
Zydus
|
3/10/2006
(77-614)
|
|
Gatifloxacin 200 mg and 400 mg tabs.
|
Dr.
Reddy's
|
3/27/2006
(76-954)
|
|
Ketotifen
fumarate ophthalmic solution 0.025%
|
Alcon
|
3/17/2006
(77-200)
|
|
Mometasone
furoate cream USP, 0.1%
|
G &
W
|
3/7/2006
(77-447)
|
|
Mometasone
furoate topical solution USP, 0.1%
|
G &
W
|
3/7/2006
(77-678)
|
|
Ondansetron
injection USP, (preservative-free) 2 mg/mL; packaged
in 4 mg/2 mL single-dose vials
|
American
|
3/7/2006
(76-972)
|
|
Ondansetron
injection USP, 2 mg/mL; packaged in 40 mg/20 mL
multiple-dose vials
|
American
|
3/7/2006
(76-974)
|
|
Rivastigmine tartrate 1.5 mg (base), 3 mg
(base), 4.5 mg (base) and 6 mg (base) caps.
|
Sun
|
3/29/2006
(77-131)
|
|
Terbinafine
hydrochloride 250 mg (base) tabs.
|
Watson
|
3/28/2006
(77-137)
|
|
Terbinafine
hydrochloride cream 1%
|
Taro
|
3/22/2006
(77-511)
|
|
Topiramate
50 mg tabs.
|
Teva
|
3/3/2006
(76-317)
|
