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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by PLIVA
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
040616
WARFARIN SODIUM
Abbreviated New Drug Application
Approval
062645
ULTRAGRIS-165
Abbreviated New Drug Application
Approval
062646
ULTRAGRIS-330
Abbreviated New Drug Application
Approval
063187
DOXYCYCLINE HYCLATE
Abbreviated New Drug Application
Approval
065218
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065223
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065225
AZITHROMYCIN
Abbreviated New Drug Application
Approval
065246
AZITHROMYCIN
Abbreviated New Drug Application
Approval
070033
METRONIDAZOLE
Abbreviated New Drug Application
Approval
070215
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Abbreviated New Drug Application
Approval
070216
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Abbreviated New Drug Application
Approval
071148
INDOMETHACIN
Abbreviated New Drug Application
Approval
071149
INDOMETHACIN
Abbreviated New Drug Application
Approval
071479
CARBAMAZEPINE
Abbreviated New Drug Application
Approval
071525
TRAZODONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
071666
IBUPROFEN
Abbreviated New Drug Application
Approval
071667
IBUPROFEN
Abbreviated New Drug Application
Approval
071668
IBUPROFEN
Abbreviated New Drug Application
Approval
071773
IBUPRIN
Abbreviated New Drug Application
Approval
072124
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072125
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072126
METHYLDOPA
Abbreviated New Drug Application
Approval
072127
METHYLDOPA
Abbreviated New Drug Application
Approval
072128
METHYLDOPA
Abbreviated New Drug Application
Approval
072316
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
072317
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
072751
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
072922
VERAPAMIL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074026
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Abbreviated New Drug Application
Approval
074072
ALBUTEROL
Abbreviated New Drug Application
Approval
074101
ATENOLOL
Abbreviated New Drug Application
Approval
074107
ATENOLOL AND CHLORTHALIDONE
Abbreviated New Drug Application
Approval
074182
NAPROXEN
Abbreviated New Drug Application
Approval
074242
NAPROXEN SODIUM
Abbreviated New Drug Application
Approval
074421
CYCLOBENZAPRINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074432
DICLOFENAC SODIUM
Abbreviated New Drug Application
Approval
074566
CIMETIDINE
Abbreviated New Drug Application
Approval
074568
CIMETIDINE
Abbreviated New Drug Application
Approval
074647
FLURBIPROFEN
Abbreviated New Drug Application
Approval
074874
PENTOXIFYLLINE
Abbreviated New Drug Application
Approval
075284
KETOROLAC TROMETHAMINE
Abbreviated New Drug Application
Approval
075337
NAPROXEN
Abbreviated New Drug Application
Approval
075362
KETOCONAZOLE
Abbreviated New Drug Application
Approval
075750
DOXAZOSIN MESYLATE
Abbreviated New Drug Application
Approval
075982
TRAMADOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076424
FLUCONAZOLE
Abbreviated New Drug Application
Approval
076426
CIPROFLOXACIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076602
CARBOPLATIN
Abbreviated New Drug Application
Approval
077232
CITALOPRAM HYDROBROMIDE
Abbreviated New Drug Application
Approval
081054
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088205
CYPROHEPTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088467
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088468
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088617
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088618
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088619
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088732
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088733
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088734
MECLIZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088883
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088884
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088885
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088886
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088887
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088888
AMITRIPTYLINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089058
BENZTROPINE MESYLATE
Abbreviated New Drug Application
Approval
089059
BENZTROPINE MESYLATE
Abbreviated New Drug Application
Approval
089060
BENZTROPINE MESYLATE
Abbreviated New Drug Application
Approval
089097
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089098
HYDRALAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
089763
THEOPHYLLINE
Abbreviated New Drug Application
Approval
089807
THEOPHYLLINE
Abbreviated New Drug Application
Approval
089808
THEOPHYLLINE
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval