Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074967
Company: AUROBINDO PHARMA USA

Products on ANDA 074967

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 074967

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/09/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74967ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2023	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/15/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/14/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/18/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/02/2011	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
09/25/2003	SUPPL-4	Labeling		Label is not available on this site.
04/28/2003	SUPPL-3	Labeling		Label is not available on this site.
08/03/1998	SUPPL-2	Labeling		Label is not available on this site.
01/27/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074967

NITROFURANTOIN

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	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	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	201722	SUN PHARM INDUSTRIES
NITROFURANTOIN	NITROFURANTOIN, MACROCRYSTALLINE	100MG	CAPSULE;ORAL	Prescription	No	AB	205005	ZYDUS PHARMS