Abbreviated
|
|
Product
|
Sponsor
|
Date
Approved
(Application No.)
|
|
Amitriptyline HCl USP, 10 mg tabs.
|
Caraco
|
6/27/2008
(40-815)
|
|
Amitriptyline HCl USP, 100 mg tabs.
|
Caraco
|
6/27/2008
(40-819)
|
|
Amitriptyline HCl USP, 150 mg tabs.
|
Caraco
|
6/27/2008
(40-820)
|
|
Amitriptyline HCl USP, 25 mg tabs.
|
Caraco
|
6/27/2008
(40-816)
|
|
Amitriptyline HCl USP, 50 mg tabs.
|
Caraco
|
6/27/2008
(40-817)
|
|
Amitriptyline HCl USP, 75 mg tabs.
|
Caraco
|
6/27/2008
(40-818)
|
|
Azithromycin for oral suspension USP, 100
mg/5 mL and 200 mg/5 mL
|
Teva
|
6/24/2008
(65-419)
|
|
Betaxolol
USP, 10 mg and 20 mg tabs.
|
KVK-Tech
|
6/27/2008
(78-962)
|
|
Carbidopa
and levodopa USP, 10 mg/100 mg, 25 mg/100 mg
and
25 mg/250 mg tabs.
|
Apotex
|
6/2/2008
(77-120)
|
|
Cetirizine
HCl Syrup, 1 mg/mL (Rx only)
|
Perrigo
|
6/17/2008
(78-398)
|
|
Cetirizine
HCl Syrup, 1 mg/mL (Rx only)
|
Ranbaxy
|
6/18/2008
(77-472)
|
|
Cetirizine
HCl Syrup, 1 mg/mL (Rx only)
|
Apotex
|
6/18/2008
(78-412)
|
|
Cetirizine
HCl Syrup, 1 mg/mL (Rx only)
|
Taro
|
6/20/2008
(76-601)
|
|
Ciclopirox
gel, 0.77%
|
Nycomed
|
6/10/2008
(77-896)
|
|
Ciprofloxacin ophthalmic solution USP, 0.3%
(base)
|
FDC
|
6/30/2008
(77-568)
|
|
Dronabinol
USP, 2.5 mg, 5 mg and 10 mg caps.
|
Par
|
6/27/2008
(78-292)
|
|
Extended
phenytoin USP, 200 mg and 300 mg caps.
|
Sun
|
6/30/2008
(40-731)
|
|
Famotidine
USP, (preservative-free) 10 mg/mL; packaged in 20
mg/2 mL single-dose vials inj.
|
Akorn-Strides
|
6/25/2008
(78-641)
|
|
Famotidine
USP, 10 mg/mL; packaged in 40 mg/4 mL and 200 mg/20
mL multiple-dose vials inj.
|
Akorn-Strides
|
6/25/2008
(78-642)
|
|
Granisetron
HCl (preservative-free), 0.1 mg (base)/mL and 1 mg
(base)/mL; packaged in 1 mL single-dose vials
inj.
|
Dr.
Reddy's
|
6/30/2008
(78-863)
|
|
Granisetron
HCl (preservative-free), 1 mg (base)/mL; packaged in
1 mL single-dose vials inj.
|
APP
|
6/30/2008
(78-096)
|
|
Granisetron
HCl (preservative-free), 1 mg (base)/mL; packaged in
1 mL single-dose vials inj.
|
Wockhardt
|
6/30/2008
(78-564)
|
|
Granisetron
HCl, 0.1 mg (base)/mL; packaged in 1 mL single-dose
vials inj.
|
Bedford
|
6/26/2008
(77-913)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 1 mL single-dose
vials inj.
|
Bedford
|
6/30/2008
(77-187)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 1 mL single-use
vials and 4 mg (base)/4 mL multiple-dose vials
inj.
|
Apotex
|
6/30/2008
(78-198)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 1 mL single-use
vials and 4 mg (base)/4 mL multiple-dose vials
inj.
|
Watson
|
6/30/2008
(78-258)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 1 mL single-use
vials and 4 mg (base)/4 mL multiple-dose vials
inj.
|
Ebewe
|
6/30/2008
(78-835)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 4 mg (base)/4 mL
multiple-dose vials inj.
|
Bedford
|
6/30/2008
(77-186)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 4 mg (base)/4 mL
multiple-dose vials inj.
|
Teva
|
6/30/2008
(77-297)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 4 mg (base)/4 mL
multiple-dose vials inj.
|
APP
|
6/30/2008
(78-090)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 4 mg (base)/4 mL
multiple-dose vials inj.
|
Wockhardt
|
6/30/2008
(78-565)
|
|
Granisetron
HCl, 1 mg (base)/mL; packaged in 4 mg (base)/4 mL
multiple-dose vials inj.
|
Dr.
Reddy's
|
6/30/2008
(78-880)
|
|
Hydromorphone HCl USP, 10 mg/mL; packaged in
10 mg/1 mL, 50 mg/5 mL and 500 mg/50 mL single-dose
vials inj.
|
Hospira
|
6/17/2008
(78-591)
|
|
Hydroxyzine
HCl USP, 10 mg, 25 mg and 50 mg tabs.
|
Sun
|
6/10/2008
(40-899)
|
|
Hydroxyzine
HCl USP, 10 mg, 25 mg and 50 mg tabs.
|
Andapharm
|
6/30/2008
(40-804)
|
|
Metoclopramide USP, 5 mg and 10 mg
tabs.
|
Ipca
|
6/12/2008
(78-807)
|
|
Metoprolol
tartrate USP, 25 mg, 50 mg and 100 mg tab.
|
OHM
|
6/17/2008
(78-459)
|
|
Moexipril
HCl, 7.5 mg and 15 mg tabs.
|
Apotex
|
6/1/2008
(78-454)
|
|
Potassium
chloride USP, 8 mEq and 10 mEq extended-release
caps.
|
Andrx
|
6/2/2008
(78-419)
|
|
Prednisolone sodium phosphate oral solution,
20 mg (base)/5 mL
|
Pharmaceutical Associates
|
6/9/2008
(78-988)
|
|
Propranolol
HCl USP, 10 mg, 20 mg, 40 mg, 60 mg and 80 mg
tabs.
|
IPCA
|
6/2/2008
(78-955)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Lupin
|
6/9/2008
(77-626)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Teva
|
6/18/2008
(77-470)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Actavis
|
6/18/2008
(77-513)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Sandoz
|
6/18/2008
(77-514)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Roxane
|
6/18/2008
(77-900)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Dr.
Reddy's
|
6/18/2008
(78-191)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Invagen
|
6/18/2008
(78-745)
|
|
Ramipril,
1.25 mg, 2.5 mg, 5 mg and 10 mg caps.
|
Apotex
|
6/18/2008
(79-116)
|
|
Risperidone
USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
tabs.
|
Teva
|
6/30/2008
(76-228)
|
|
Sterile
vancomycin HCl USP, 500 mg (base)/vial, 1 g
(base)/vial
|
Generamedix
|
6/30/2008
(65-401)
|
|
Torsemide,
10 mg/mL; packaged in 20 mg/2 mL and 50 mg/5 mL
single-use vials inj.
|
Bedford
|
6/10/2008
(78-007)
|
|
Trandolapril, 1 mg, 2 mg and 4 mg
tabs.
|
Glenmark
|
6/18/2008
(78-508)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Sandoz
|
6/13/2008
(77-515)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Mylan
|
6/13/2008
(77-166)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Zydus
|
6/13/2008
(77-653)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Dr.
Reddy's
|
6/13/2008
(78-301)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Pliva
|
6/13/2008
(78-517)
|
|
Venlafaxine
HCl, 25 mg (base), 37.5 mg (base), 50 mg (base), 75
mg (base) and 100 mg (base) tabs.
|
Caraco
|
6/13/2008
(78-627)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Roxane
|
6/6/2008
(77-237)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Genpharm
|
6/6/2008
(77-238)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Teva
|
6/6/2008
(77-239)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Sandoz
|
6/6/2008
(78-095)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Upsher-Smith
|
6/6/2008
(78-706)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Aurobindo
|
6/6/2008
(78-829)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Unichem
|
6/6/2008
(78-989)
|
|
Zalepon, 5
mg and 10 mg caps.
|
Cipla
|
6/20/2008
(77-505)
|
|
Zidovudine
oral solution USP, 50 mg/5 mL
|
Cipla
|
6/26/2008
(77-981)
|
|
Tentative
Abbreviated
|
|
Adenosine
USP, 3 mg/mL inj.
|
Bedford
|
6/26/2008
(78-618)
|
|
Almotriptan
malate, 6.25 mg (base) and 12.5 mg (base)
tabs.
|
Teva
|
6/9/2008
(78-027)
|
|
Anastrozole, 1 mg tabs.
|
Sandoz
|
6/25/2008
(79-007)
|
|
Buprenorphine HCl sublingual, 2 mg (base)
and 8 mg (base) tabs.
|
Roxane
|
6/18/2008
(78-633)
|
|
Escitalopram oxalate, 10 mg (base) and 20 mg
(base) tabs.
|
Lupin
|
6/12/2008
(78-169)
|
|
Irbesartan
and hydrochlorothiazide, 150 mg/12.5 mg and 300
mg/12.5 mg tabs.
|
Mylan
|
6/10/2008
(77-969)
|
|
Lamotrigine, 2 mg, 5 mg and 25 mg chewable,
dispersible tabs.
|
Cobalt
|
6/25/2008
(76-928)
|
|
Linezolid,
600 mg tabs.
|
Mylan
|
6/26/2008
(78-845)
|
|
Valganciclovir HCl, 450 mg tabs.
|
Ranbaxy
|
6/20/2008
(78-078)
|
|
Valsartan,
40 mg, 80 mg, 160 mg and 320 mg tabs.
|
Ivax
|
6/10/2008
(77-530)
|
