Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020064
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACROBID NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/24/1991 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/07/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/06/2013 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020064s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020064Orig1s021ltr.pdf
06/06/2011 SUPPL-20 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf
03/05/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020064s019ltr.pdf
06/27/2007 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020064s017ltr.pdf
10/30/2003 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr014ltr.pdf
02/04/2003 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr013ltr.pdf
11/03/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/17/1998 SUPPL-9 Labeling

Label is not available on this site.

07/16/1997 SUPPL-8 Labeling

Label is not available on this site.

03/27/1997 SUPPL-7 Labeling

Label is not available on this site.

02/13/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/17/1998 SUPPL-5 Labeling

Label is not available on this site.

08/23/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1996 SUPPL-2 Labeling

Label is not available on this site.

07/24/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2013 SUPPL-21 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020064s021lbl.pdf
03/05/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf
10/30/2003 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf

MACROBID

CAPSULE;ORAL; 75MG;25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MACROBID NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription Yes AB 020064 ALVOGEN
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription No AB 207372 AMNEAL PHARMS
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription No AB 076648 MYLAN
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription No AB 077066 SANDOZ
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription No AB 208516 SUNNY PHARMTECH INC
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG CAPSULE;ORAL Prescription No AB 202250 WATSON LABS INC

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