Abbreviated
|
|
Product
|
Sponsor
|
Date
Approved
(Application No.)
|
|
Adenosine
injection, USP 3 mg/mL; packaged in 6 mg/2 mL and 12
mg/4 mL single-use vials
|
American
Pharmaceutical
|
4/27/2005
(77-133)
|
|
Amiodarone
HCl injection 50 mg/mL
|
Apotex
|
4/20/2005
(77-161)
|
|
Amiodarone
hydrochloride 200 mg and 400 mg tabs.
|
Aurosal
|
4/8/2005
(77-069)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Watson
|
4/18/2005
(76-417)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Ivax
|
4/18/2005
(76-468)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Roxane
|
4/18/2005
(76-489)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Barr
|
4/18/2005
(76-530)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Eon
|
4/18/2005
(76-683)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Mylan
|
4/18/2005
(76-811)
|
|
Anagrelide
HCl 0.5 mg (base) and 1 mg (base) caps.
|
Impax
|
4/18/2005
(76-910)
|
|
Bromocriptine mesylate capsules, USP 5 mg
(base)
|
Mylan
|
4/4/2005
(77-226)
|
|
Cefazolin
for injection USP 500 mg/vial and 1 g/vial
|
Orchid
Healthcare
|
4/21/2005
(65-226)
|
|
Ciclopirox
olamine cream, USP 0.77%
|
Taro
|
4/12/2005
(76-790)
|
|
Citalopram
hydrobromide 10 mg (base), 20 mg (base) and 40 mg
(base) tabs.
|
Akyma
|
4/29/2005
(77-045)
|
|
Clozapine
USP 25 mg and 100 mg tabs.
|
Teva
|
4/26/2005
(75-162)
|
|
Dexamethasone sodium phosphate injection,
USP 10 mg/mL (as dexamethasone phosphate) (preserved)
multi-dose vials
|
American
Pharmaceutical
|
4/22/2005
(40-572)
|
|
Estradiol
and estradiol/norgestimate 1 mg and 1 mg/0.09 mg
tabs.
|
Barr
|
4/29/2005
(76-812)
|
|
Fexofenadine hydrochloride and
pseudoephedrine hydrochloride 60 mg/120 mg
extended-release tabs.
|
Barr
|
4/14/2005
(76-236)
|
|
Fosinopril
sodium 10 mg, 20 mg and 40 mg tabs.
|
Invagen
|
4/20/2005
(77-222)
|
|
Gabapentin
capsules 100 mg, 300 mg and 400 mg
|
Apotex
|
4/6/2005
(75-360)
|
|
Gabapentin
capsules 100 mg, 300 mg and 400 mg
|
Eon
|
4/6/2005
(75-539)
|
|
Ketoconazole shampoo 2%
|
QLT
USA
|
4/11/2005
(76-942)
|
|
Metformin
HCl 500 mg extended-release tabs.
|
Zydus
|
4/20/2005
(77-060)
|
|
Metformin
HCl 500 mg, 850 mg and 1,000 mg tabs.
|
Zydus
|
4/18/2005
(77-064)
|
|
Metformin
HCl 750 mg extended-release tabs.
|
Zydus
|
4/21/2005
(77-078)
|
|
Metformin
hydrochloride 750 mg extended-release
|
Purepac
|
4/13/2005
(76-878)
|
|
Metformin
hydrochloride 750 mg extended-release tabs.
|
Teva
|
4/12/2005
(76-864)
|
|
Metformin
hydrochloride 750 mg extended-release tabs.
|
Andrx
|
4/12/2005
(76-869)
|
|
Mometasone
furoate cream, USP 0.1%
|
Altana
|
4/8/2005
(76-171)
|
|
Mometasone
furoate topical solution, USP 0.1%
|
Aigis
|
4/6/2005
(77-180)
|
|
Naproxen
USP 250 mg, 375 mg and 500 mg tabs.
|
Perrigo
|
4/27/2005
(77-339)
|
|
Niacin
1,000 mg extended-release tabs.
|
Barr
|
4/14/2005
(76-250)
|
|
Niacin 500
mg and 750 mg extended-release tabs.
|
Barr
|
4/26/2005
(76-378)
|
|
Nitrofurantoin monohydrate/macrocrystals
capsules 100 mg
|
Eon
|
4/5/2005
(77-066)
|
|
Norethindrone acetate and ethinyl estradiol
tabs. USP and ferrous fumarate 1.5 mg/0.03 mg/75 mg
tabs.
|
Andrx
|
4/28/2005
(77-075)
|
|
Octreotide
acetate injection 0.2 mg/mL (base), 1 mg/mL
(base)
|
Bedford
|
4/8/2005
(76-330)
|
|
Phentermine
HCl USP 37.5 mg tabs.
|
Lannett
Holdings
|
4/15/2005
(40-555)
|
|
Prednisolone sodium phosphate oral solution
15 mg (base)/5 mL
|
Pharmaceutical Associates
|
4/25/2005
(76-913)
|
|
Propofol
injectable emulsion 10 mg/mL; packaged in 20 mL, 50
mL and 100 mL single-dose vials
|
Bedford
|
4/19/2005
(74-848)
|
|
Tramadol
HCl and acetaminophen 37.5 mg/325 mg tabs.
|
Kali
|
4/21/2005
(76-475)
|
|
Vinorelbine
tartrate injection 10 mg (base)/mL; packaged in 10 mg
(base)/1 mL and 50 mg (base)/5 mL single-use
vials
|
American
|
4/18/2005
(76-849)
|
|
Supplemental Abbreviated
|
|
Amiodarone
hydrochloride 100 mg tabs. (new strength)
|
Upsher-Smith
|
4/12/2005
(75-135/010, 011)
|
|
Clozapine
USP 50 mg tabs. (new strength)
|
Ivax
|
4/25/2005
(74-949/030)
|
|
Doxycycline
capsules, USP 75 mg (new strength)
|
Par
|
4/18/2005
(65-055/003)
|
|
Gabapentin
600 mg and 800 mg tabs. (additional strengths)
|
Ivax
|
4/29/2005
(76-017/006)
|
|
Tentative Abbreviated
|
|
Betamethasone dipropionate lotion, USP
(augmented) 0.05%
|
Altana
|
4/22/2005
(77-111)
|
|
Sertraline
hydrochloride 25 mg (base), 50 mg (base) and 100 mg
(base) tabs.
|
Roxane
|
4/11/2005
(76-881)
|
|
Terbinafine
hydrochloride 250 mg (base) tabs.
|
Mylan
|
4/12/2005
(77-195)
|
