|
Product |
Established Name |
NDA/Supp no. |
Oct 2 |
MOTRIN IB |
ibuprofen
tablets |
19-012/S-024 |
|
ANECTINE |
succinylcholine
chloride injection |
08-453/S-019 |
|
Oct 3 |
TRACRIUM |
atracurium
besylate injection |
18-831/S-022 |
|
CHLOROPTIC |
chloramphenicol
ophthalmic solution |
50-091/S-008 |
|
MIRCETTE |
desogestrel
and ethinyl estradiol tablets |
20-713/S-007 |
|
ARTHROTEC |
diclofenac
sodium/misoprostol tablets |
20-607/S-005 |
|
Oct 4 |
SANDIMMUNE |
cyclosporine
oral solution |
50-573/S-018 |
|
SANDIMMUNE |
cyclosporine
capsules |
50-574/S-025 |
|
SANDIMMUNE |
cyclosporine
injection |
50-625/S-027 |
|
NEORAL |
cyclosporine
capsules [modified] |
50-716/S-011 |
|
NEORAL |
cyclosporine
oral solution [modified] |
50-715/S-007 |
|
ALTACE |
ramipril
capsules |
19-901/S-028 |
|
Oct 5 |
PLAQUENIL |
hydroxychloroquine
sulfate tablets |
09-768/S-033 |
|
Oct 6 |
LESCOL |
fluvastatin
sodium capsules |
20-261/S-028 |
|
NTG IN DEXTROSE 5% |
nitroglycerin
injection |
19-970/S-011 |
|
Oct 10 |
CARDURA |
doxazosin
mesylate tablets |
19-668/S-014 |
|
LOZOL |
indapamide
tablets |
18-538/S-026 |
|
Oct 12 |
NEURONTIN |
gabapentin
oral solution |
20-235/S-015 |
|
NEURONTIN |
gabapentin
capsules |
21-129/S-005 |
|
NEURONTIN |
gabapentin
tablets |
20-882/S-002 |
|
Oct 17 |
DOLOPHINE |
methadone
HCl injection |
06-134/S-023 |
|
SINGULAIR |
montelukast
sodium chewable tablets |
20-830/S-010 |
|
SINGULAIR |
montelukast
sodium tablets |
20-829/S-009 |
|
Oct 20 |
FOSAMAX |
alendronate
sodium tablets |
20-560/S-021 |
|
BIAXIN |
clarithromycin
tablets |
50-662/S-029 |
|
Oct 23 |
CRIXIVAN |
indinavir
sulfate capsules |
20-685/S-045 |
|
Oct 27 |
SEROSTIM |
somatropin
for injection |
20-604/S-010 |
|
Oct 31 |
CAFERGOT |
ergotamine
tartrate/caffeine supp |
09-000/S-021 |
|
TALACEN |
pentazocine
HCl/acetaminophen tablets |
18-458/S-010 |
|