Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016620
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Prescription AB Yes No
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Prescription AB Yes Yes
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Prescription AB Yes 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
06/05/1970 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
10/15/2015 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

09/06/2013 SUPPL-72 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/2013/016620s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016620Orig1s072ltr.pdf
06/06/2011 SUPPL-70 Labeling 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-68 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016620s068ltr.pdf
09/14/2007 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016620s067ltr.pdf
03/29/2004 SUPPL-65 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16620slr065ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016620_S065_MACRODANTIN.pdf
02/04/2003 SUPPL-64 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16620slr064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016620_S064_MACRODANTIN.pdf
10/21/1998 SUPPL-63 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016620_S063_MACRODANTIN.pdf
07/16/1997 SUPPL-62 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016620_S062_MACRODANTIN.pdf
03/27/1997 SUPPL-61 Labeling

Label is not available on this site.

07/30/1996 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-59 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S059_MACRODANTIN.pdf
02/17/1998 SUPPL-58 Labeling

Label is not available on this site.

08/09/1993 SUPPL-57 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S057_MACRODANTIN.pdf
02/17/1998 SUPPL-56 Labeling

Label is not available on this site.

12/08/1992 SUPPL-55 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S055_MACRODANTIN.pdf
12/08/1992 SUPPL-54 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S054_MACRODANTIN.pdf
12/08/1992 SUPPL-53 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S053_MACRODANTIN.pdf
12/08/1992 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/10/1991 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1990 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/1990 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/03/1989 SUPPL-47 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16620_S047_MacrodantinTOC.cfm
05/13/1988 SUPPL-45 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm
05/19/1993 SUPPL-39 Labeling

Label is not available on this site.

07/09/1984 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/02/1983 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/18/1993 SUPPL-36 Labeling

Label is not available on this site.

05/13/1982 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/12/1980 SUPPL-32 Labeling

Label is not available on this site.

10/15/1982 SUPPL-31 Labeling

Label is not available on this site.

08/14/1980 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/20/1980 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1979 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/18/1979 SUPPL-26 Labeling

Label is not available on this site.

07/26/1979 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/28/1978 SUPPL-23 Labeling

Label is not available on this site.

05/13/1977 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1977 SUPPL-20 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S020_Macrodantin Capsules.pdf
11/22/1976 SUPPL-19 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S019_Macrodantin Capsules.pdf
07/21/1976 SUPPL-18 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S018_Macodantin.pdf
07/21/1976 SUPPL-17 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S017_Macrodantin Capsules.pdf
07/15/1976 SUPPL-16 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S016_Macrodantin Capsules.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2013 SUPPL-72 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/2013/016620s072lbl.pdf
03/05/2009 SUPPL-68 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf
09/14/2007 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf
03/29/2004 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf

MACRODANTIN

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
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 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
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 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

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
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

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