Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091095
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Prescription AB No No
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription AB No No
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/18/2015 ORIG-1 Approval

Label is not available on this site.

NITROFURANTOIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Prescription Yes AB 016620 ALVOGEN MALTA
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Prescription No AB 091095 ACTAVIS LABS FL INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Prescription No AB 201722 SUN PHARM INDUSTRIES

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription Yes AB 016620 ALVOGEN MALTA
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 091095 ACTAVIS LABS FL INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 073671 IMPAX LABS INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 074967 MYLAN
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 203233 NOVEL LABS INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 201722 SUN PHARM INDUSTRIES
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription No AB 205005 ZYDUS PHARMS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription Yes AB 016620 ALVOGEN MALTA
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 091095 ACTAVIS LABS FL INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 073652 IMPAX LABS INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 077025 MYLAN
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 203233 NOVEL LABS INC
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 201722 SUN PHARM INDUSTRIES
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription No AB 205005 ZYDUS PHARMS

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