FDA's ANDA Approvals
|
|
Applicant
|
Active
Ingredients
|
Number
|
Date
Approved
|
|
Ranbaxy
|
Hydrochlorothiazide/quinapril HCl, 12.5 mg; EQ
10 mg base, 12.5 mg; EQ 20 mg base and 25 mg; EQ 20 mg
base tabs.
|
78-211
|
3/4/2009
|
|
Austarpharma
|
Sertraline
HCl, EQ 25 mg base, EQ 50 mg base and EQ 100 mg base
tabs.
|
78-677
|
3/4/2009
|
|
Sandoz
|
Methylprednisolone acetate, 40 mg/mL 80 mg/mL
inj.
|
40-794
|
3/5/2009
|
|
West
Ward
|
Glycopyrrolate, 1 mg and 2 mg tabs.
|
40-836
|
3/5/2009
|
|
Zydus
|
Divalproex
sodium, EQ 125 mg, EQ 250 mg and EQ 500 mg valproic
acid delayed-release tabs.
|
44-100
|
3/5/2009
|
|
Upsher
Smith
|
Propranolol
HCl, 60 mg, 80 mg, 120 mg and 160 mg extended-release
caps.
|
78-311
|
3/6/2009
|
|
Synerx
|
Malathion,
0.5% topical lotion
|
78-743
|
3/6/2009
|
|
Ranbaxy
|
Ramipril, 5
mg and 10 mg caps.
|
78-849
|
3/6/2009
|
|
Avanthi
|
Indomethacin,
75 mg extended-release caps.
|
79-175
|
3/6/2009
|
|
Sun
|
Leuprolide
acetate, 1 mg/0.2 mL inj.
|
78-885
|
3/9/2009
|
|
Generamedix
|
Pamidronate
disodium, 30 mg/vial and 90 mg/vial inj.
|
78-300
|
3/10/2009
|
|
Akorn
|
Apraclonidine
HCl, EQ 0.5% base ophthalmic solution/drops
|
77-764
|
3/12/2009
|
|
Sun
|
Promethazine
HCl, 6.25 mg/5 mL syrup
|
40-891
|
3/13/2009
|
|
Apotex
|
Levetiracetam, 250 mg, 500 mg, 750 mg and 1 g
tabs.
|
78-869
|
3/13/2009
|
|
Dr.
Reddy's
|
Omeprazole,
10 mg and 20 mg delayed-release pellets caps.
|
78-693
|
3/16/2009
|
|
Barr
|
Minocycline
HCl, EQ 45 mg base, EQ 90 mg base and EQ 135 mg base
extended-release tabs.
|
65-485
|
3/17/2009
|
|
Kudco
|
Pantoprazole
sodium, EQ 20 mg base and EQ 40 mg base delayed-release
tabs.
|
78-281
|
3/17/2009
|
|
Mylan
|
Divalproex
sodium, EQ 125 mg, EQ 250 mg and 500 mg valproic acid
delayed-release tabs.
|
90-062
|
3/17/2009
|
|
Cephazone
|
Cefazolin
sodium, EQ 500 mg base/vial and EQ 1 g base/vial
inj.
|
65-280
|
3/18/2009
|
|
Cephazone
|
Cefazolin
sodium, EQ 10 mg base/vial inj.
|
65-295
|
3/18/2009
|
|
Cephazone
|
Cefazolin
sodium, EQ 20 mg base/vial inj.
|
65-296
|
3/18/2009
|
|
Aurobindo
|
Fluoxetine
HCl, EQ 20 mg base/5 mL oral solution
|
79-209
|
3/19/2009
|
|
Alembic
|
Fluoxetine
HCl, 10 mg, 20 mg and 40 mg caps.
|
90-223
|
3/19/2009
|
|
Cipla
|
Levetiracetam, 250 mg, 500 mg and 750 mg
tabs.
|
77-319
|
3/20/2009
|
|
Cipla
|
Stavudine, 1
mg/mL oral solution
|
78-030
|
3/20/2009
|
|
Dey
|
Levalbuterol
HCl, EQ 0.25% base inhalation solution
|
78-309
|
3/20/2009
|
|
Coastal
Pharms
|
Liothyronine
sodium, EQ 0.005 mg base, EQ 0.025 mg base and EQ 0.05
mg base tabs.
|
90-097
|
3/20/2009
|
|
Hikma
Farmaceutica
|
Flumazenil,
0.5 mg/5 mL (0.1 mg/mL) and 1 mg/10 mL (0.1 mg/mL)
inj.
|
78-527
|
3/23/2009
|
|
Perrigo
|
Sulfacetamide
sodium, 10% topical lotion
|
78-649
|
3/23/2009
|
|
Cadista
Pharms
|
Risperidone,
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg tabs.
|
78-828
|
3/23/2009
|
|
Sagent
Strides
|
Azithromycin,
EQ 500 mg base/vial inj.
|
65-506
|
3/24/2009
|
|
Watson
|
Bupropion
HCl, 150 mg extended-release tabs.
|
79-094
|
3/24/2009
|
|
Watson
|
Bupropion
HCl, 100 mg, 150 mg and 200 mg extended-release
tabs.
|
79-095
|
3/24/2009
|
|
Roxane
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
76-306
|
3/27/2009
|
|
Par
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
76-311
|
3/27/2009
|
|
Mylan
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
76-314
|
3/27/2009
|
|
Barr
|
Topiramate,
25 mg, 100 mg and 200 mg tabs.
|
76-315
|
3/27/2009
|
|
Teva
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
76-317
|
3/27/2009
|
|
Ranbaxy
|
Topiramate,
25 mg, 100 mg and 200 mg tabs.
|
76-327
|
3/27/2009
|
|
Cipla
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
76-343
|
3/27/2009
|
|
Glenmark
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
77-627
|
3/27/2009
|
|
Cobalt
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
77-643
|
3/27/2009
|
|
Apotex
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
77-733
|
3/27/2009
|
|
Zydus
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
78-235
|
3/27/2009
|
|
Aurobindo
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
78-462
|
3/27/2009
|
|
Torrent
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
79-153
|
3/27/2009
|
|
Unichem
|
Topiramate,
25 mg, 50 mg and 100 mg tabs.
|
90-162
|
3/27/2009
|
|
Sun
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
90-278
|
3/27/2009
|
|
KVK
|
Sodium
polystyrene sulfonate, 454 mg/bottle oral rectal
powder
|
40-905
|
3/30/2009
|
|
Pliva
Hrvatska Doo
|
Topiramate,
25 mg, 50 mg, 100 mg and 200 mg tabs.
|
77-905
|
3/30/2009
|
|
Apotex
|
Budesonide,
0.25 mg/2mL inhalation suspension
|
78-202
|
3/30/2009
|
|
Tentative Approvals
|
|
Sandoz
|
Rosiglitazone
maleate, 2 mg, 4 mg and 8 mg tabs.
|
78-674
|
3/9/2009
|
|
Alcon
|
Ketorolac
tromethamine, 0.5% ophthalmic solution
|
76-583
|
3/10/2009
|
|
Matrix
|
Lopinavir/ritonavir, 200 mg; 50 mg
tabs.
|
79-074
|
3/10/2009
|
|
Aurobindo
|
Lopinavir/ritonavir, 100 mg; 25 mg and 200 mg;
50 mg tabs.
|
90-471
|
3/10/2009
|
|
Teva
|
Divalproex
sodium, 500 mg extended-release tabs.
|
78-700
|
3/16/2009
|
|
Alkem
|
Lamivudine,
150 mg tabs.
|
90-433
|
3/16/2009
|
|
Pharmacare
|
Stavudine/lamivudine, 30 mg; 150 mg and 40 mg;
150 mg tabs.
|
22-347
|
3/18/2009
|
|
Dr.
Reddy's
|
Risperidone,
1 mg/mL oral solution
|
78-909
|
3/20/2009
|
|
Apotex
|
Azelastine
HCl, 0.05% ophthalmic solution
|
78-621
|
3/23/2009
|
|
Matrix
|
Emtricitabine/tenofovir disoproxil fumarate,
200 mg/300 mg tabs.
|
90-049
|
3/30/2009
|
|
Aurobindo
|
Emtricitabine/tenofovir disoproxil fumarate,
200 mg/300 mg tabs.
|
90-513
|
3/30/2009
|
|
Matrix
|
Abacavir
sulfate/lamivudine, 600 mg/300 mg tabs.
|
90-519
|
3/30/2009
|
