|
Product |
Established Name |
NDA/Supp # |
July
3 |
BACTRIM DS |
trimethoprim/sulfamethoxazole
tablets |
17-377/S-050 |
VIDEX |
didanosine
tablets |
20-154/S-031 |
didanosine
for oral solution |
20-155/S-022 |
|
|
|
|
July
6 |
COPAXONE |
glatimer
acetate for injection |
20-622/S-009 |
PHOTOFRIN |
porfimer
sodium injection |
20-451/S-006 |
|
|
|
|
July
7 |
ACULAR PF |
ketorolac
tromethamine ophthalmic solution |
20-811/S-002 |
BETAPACE |
sotalol
HCl tablets |
19-865/S-011 |
CILOXAN |
ciprofloxacin
HCl ophthalmic ointment |
20-369/S-004 |
|
|
|
|
July
11 |
AVANDIA |
rosiglitazone
tablets |
21-071/S-002 |
GENOTROPIN |
somatropin
(rDNA origin) for injection |
20-280/S-025 |
PROCAINBID |
procainamide
HCl tablets |
20-545/S-004 |
|
|
|
|
July
12 |
NORVASC |
amlodipine
besylate tablets |
19-787/S-017 |
VASCOR |
bepridil
HCl tablets |
19-002/S-009 |
|
|
|
|
July 14 |
FEMHRT |
norethindrone
acetate/ethinyl estradiol tablets |
21-065/S-004 |
|
|
|
|
July 17 |
SEROSTIM |
somatropin
(rDNA origin) for injection |
20-604/S-009 |
|
|
|
|
July 18 |
LEXXEL |
enalapril
maleate/felodipine tablets |
20-668/S-006 |
|
|
|
|
July
24 |
TRASYLOL |
aprotinin
injection |
20-304/S-009 |
VIDEX |
didanosine
tablets |
20-154/S-032 |
|
didanosine
for oral solution |
20-155/S-023 |
|
|
|
|
July 25 |
TYLENOL |
actaminophen
extended-release tablet |
19-872/S-010 |
|
|
|
|
July
26 |
SERZONE |
nefazadone
HCl tablets |
20-152/S-006 |
THAM |
tromethamine
injection |
13-025/S-035 |
|
|
|
|
July
27 |
CELLCEPT |
mycophenolate
mofetil HCl for injection |
50-758/S-003 |
|
mycophenolate
mofetil capsules |
50-722/S-004 |
|
mycophenolate
mofetil tablets |
50-723/S-003 |
|
mycophenolate
mofetil for oral suspension |
50-759/S-004 |
ZIAGEN |
abacavir
sulfate oral solution |
20-978/S-004 |
|
abacavir
sulfate tablets |
20-977/S-003 |
|
|
|
|
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