Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073671
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROFURANTOIN NITROFURANTOIN, MACROCRYSTALLINE 50MG 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
01/28/1993 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

10/12/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

04/15/2009 SUPPL-29 Labeling

Label is not available on this site.

01/16/2008 SUPPL-28 Labeling

Label is not available on this site.

01/16/2008 SUPPL-27 Labeling

Label is not available on this site.

04/17/2015 SUPPL-25 Labeling

Label is not available on this site.

07/13/2007 SUPPL-22 Labeling

Label is not available on this site.

07/29/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-8 Labeling

Label is not available on this site.

08/02/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1999 SUPPL-6 Labeling

Label is not available on this site.

01/28/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

09/14/1999 SUPPL-4 Labeling

Label is not available on this site.

02/13/1998 SUPPL-3 Labeling

Label is not available on this site.

05/12/1997 SUPPL-2 Labeling

Label is not available on this site.

05/21/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 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

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