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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by HI TECH PHARMA
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
012179
VOSOL
New Drug Application
Approval
New combination
(S) Standard review drug
012770
VOSOL HC
New Drug Application
Approval
New combination
(S) Standard review drug
040010
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040014
LIDOCAINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040026
PROMETHAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040027
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Abbreviated New Drug Application
Approval
040119
ACETAMINOPHEN AND CODEINE PHOSPHATE
Abbreviated New Drug Application
Approval
040125
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040126
THIORIDAZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
040151
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Abbreviated New Drug Application
Approval
040613
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Abbreviated New Drug Application
Approval
064042
NYSTATIN
Abbreviated New Drug Application
Approval
064101
ERYTHRO-STATIN
Abbreviated New Drug Application
Approval
072416
DIPHENHYDRAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074076
LACTULOSE
Abbreviated New Drug Application
Approval
074077
LACTULOSE
Abbreviated New Drug Application
Approval
074170
AMANTADINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074220
CORMAX
Abbreviated New Drug Application
Approval
074221
EMBELINE
Abbreviated New Drug Application
Approval
074222
EMBELINE
Abbreviated New Drug Application
Approval
074352
LOPERAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074356
CHLORHEXIDINE GLUCONATE
Abbreviated New Drug Application
Approval
074543
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
074650
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Abbreviated New Drug Application
Approval
074664
CIMETIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074731
MINOXIDIL (FOR MEN)
MINOXIDIL (FOR WOMEN)
Abbreviated New Drug Application
Approval
074749
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
075063
ALBUTEROL SULFATE
Abbreviated New Drug Application
Approval
075163
TIMOLOL MALEATE
Abbreviated New Drug Application
Approval
075183
PREDNISOLONE SODIUM PHOSPHATE
Abbreviated New Drug Application
Approval
075325
EMBELINE E
Abbreviated New Drug Application
Approval
075525
FLUOXETINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
075958
MIDAZOLAM HYDROCHLORIDE
Abbreviated New Drug Application
Approval
076141
EMBELINE
Abbreviated New Drug Application
Approval
076290
LIDOCAINE AND PRILOCAINE
Abbreviated New Drug Application
Approval
076615
OFLOXACIN
Abbreviated New Drug Application
Approval
076616
OFLOXACIN
Abbreviated New Drug Application
Approval
077026
ACYCLOVIR
Abbreviated New Drug Application
Approval
077399
LEVOCARNITINE
Abbreviated New Drug Application
Approval
077570
FLUTICASONE PROPIONATE
Abbreviated New Drug Application
Approval
077579
CALCIPOTRIENE
Abbreviated New Drug Application
Approval
077846
DORZOLAMIDE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
077847
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Abbreviated New Drug Application
Approval
078270
CICLOPIROX
Abbreviated New Drug Application
Approval
078974
GABAPENTIN
Abbreviated New Drug Application
Approval
091078
RANITIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
091678
LEVOFLOXACIN
Abbreviated New Drug Application
Approval
Back to Companies who have applied for FDA Drug Approval