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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by MYLAN LABS LTD
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
040802
DEXAMETHASONE SODIUM PHOSPHATE
Abbreviated New Drug Application
Approval
040803
DEXAMETHASONE SODIUM PHOSPHATE
Abbreviated New Drug Application
Approval
065397
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065407
TOBRAMYCIN SULFATE
Abbreviated New Drug Application
Approval
065421
RIFAMPIN
Abbreviated New Drug Application
Approval
065432
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
065458
PIPERACILLIN AND TAZOBACTAM
Abbreviated New Drug Application
Approval
075375
DILTIAZEM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075440
HALOPERIDOL DECANOATE
Abbreviated New Drug Application
Approval
075769
DIPYRIDAMOLE
Abbreviated New Drug Application
Approval
075918
FLUPHENAZINE DECANOATE
Abbreviated New Drug Application
Approval
076888
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
076889
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
078244
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
078257
ONDANSETRON HYDROCHLORIDE
Abbreviated New Drug Application
Approval
078289
ETOMIDATE
Abbreviated New Drug Application
Approval
078299
KETOROLAC TROMETHAMINE
Abbreviated New Drug Application
Approval
078347
HALOPERIDOL
Abbreviated New Drug Application
Approval
078520
PAMIDRONATE DISODIUM
Abbreviated New Drug Application
Approval
078562
MIVACURIUM CHLORIDE
Abbreviated New Drug Application
Approval
078595
FLUMAZENIL
Abbreviated New Drug Application
Approval
078640
ADENOSINE
Abbreviated New Drug Application
Approval
078641
FAMOTIDINE
Abbreviated New Drug Application
Approval
078642
FAMOTIDINE PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
078686
ADENOSINE
Abbreviated New Drug Application
Approval
078736
FOSPHENYTOIN SODIUM
Abbreviated New Drug Application
Approval
079076
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
090243
VECURONIUM BROMIDE
Abbreviated New Drug Application
Approval
090665
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
090866
VALSARTAN
Abbreviated New Drug Application
Approval
091056
LIDOCAINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091058
LIDOCAINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091062
CISPLATIN
Abbreviated New Drug Application
Approval
091063
CARBOPLATIN
Abbreviated New Drug Application
Approval
091358
OXALIPLATIN
Abbreviated New Drug Application
Approval
091406
DOXYCYCLINE
Abbreviated New Drug Application
Approval
091469
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091478
CARBOPLATIN
Abbreviated New Drug Application
Approval
091486
OXACILLIN SODIUM
Abbreviated New Drug Application
Approval
091510
CARBOPLATIN
Abbreviated New Drug Application
Approval
091540
PACLITAXEL
Abbreviated New Drug Application
Approval
091542
TOPOTECAN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091554
VANCOMYCIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091599
EPIRUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200002
NAFCILLIN SODIUM
Abbreviated New Drug Application
Approval
200144
IDARUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200145
GEMCITABINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200148
VINORELBINE TARTRATE
Abbreviated New Drug Application
Approval
200170
DOXORUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200510
CLADRIBINE
Abbreviated New Drug Application
Approval
200647
FLUDARABINE PHOSPHATE
Abbreviated New Drug Application
Approval
200648
FLUDARABINE PHOSPHATE
Abbreviated New Drug Application
Approval
200901
DOXORUBICIN HYDROCHLORIDE
Abbreviated New Drug Application
Approval
200914
CYTARABINE
Abbreviated New Drug Application
Approval
200979
OXALIPLATIN
Abbreviated New Drug Application
Approval
201014
MITOXANTRONE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
201024
AMPICILLIN AND SULBACTAM
Abbreviated New Drug Application
Approval
201025
AMPICILLIN SODIUM
Abbreviated New Drug Application
Approval
201155
KETOROLAC TROMETHAMINE
Abbreviated New Drug Application
Approval
201529
METHOTREXATE SODIUM PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
201530
METHOTREXATE SODIUM PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
201689
IFOSFAMIDE
Abbreviated New Drug Application
Approval
201784
CYTARABINE
Abbreviated New Drug Application
Approval
202197
AMPICILLIN AND SULBACTAM
Abbreviated New Drug Application
Approval
202198
AMPICILLIN SODIUM
Abbreviated New Drug Application
Approval
202242
LIDOCAINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
202650
ZOLEDRONIC ACID
Abbreviated New Drug Application
Approval
202668
FLUOROURACIL
Abbreviated New Drug Application
Approval
202669
FLUOROURACIL
Abbreviated New Drug Application
Approval
202671
IBANDRONATE SODIUM
Abbreviated New Drug Application
Approval
203308
LEVETIRACETAM
Abbreviated New Drug Application
Approval
203322
SUMATRIPTAN SUCCINATE
Abbreviated New Drug Application
Approval
203364
MESNA
Abbreviated New Drug Application
Approval
204311
ABACAVIR AND LAMIVUDINE
New Drug Application
Tentative Approval
New manufacturer
204915
ABACAVIR AND LAMIVUDINE
New Drug Application
Tentative Approval
New formulation
205921
NEVIRAPINE
Abbreviated New Drug Application
Tentative Approval
206040
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
New Drug Application
Tentative Approval
New combination
206041
ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE
New Drug Application
Tentative Approval
New combination
206042
EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE
New Drug Application
Tentative Approval
New combination
Back to Companies who have applied for FDA Drug Approval