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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211935
Company: ALEMBIC

Products on ANDA 211935

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211935

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211935

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	ALMATICA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE;ORAL	Prescription	No	AB	211935	ALEMBIC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE;ORAL	Prescription	No	AB	077025	AUROBINDO PHARMA USA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	25MG	CAPSULE;ORAL	Prescription	No	AB	217272	MANKIND PHARMA

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	ALMATICA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE;ORAL	Prescription	No	AB	211935	ALEMBIC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE;ORAL	Prescription	No	AB	074967	AUROBINDO PHARMA USA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE;ORAL	Prescription	No	AB	073671	IMPAX LABS INC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE;ORAL	Prescription	No	AB	217272	MANKIND PHARMA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	50MG	CAPSULE;ORAL	Prescription	No	AB	203233	NOVEL LABS INC
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	ALMATICA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	211935	ALEMBIC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	074967	AUROBINDO PHARMA USA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	077025	AUROBINDO PHARMA USA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	073652	IMPAX LABS INC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	217272	MANKIND PHARMA
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	203233	NOVEL LABS INC
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	205005	ZYDUS PHARMS

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