Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076648
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE 75MG;25MG 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
03/22/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76648ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2004/076648_ORIGINAL_APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2016 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/20/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/24/2008 SUPPL-4 Labeling

Label is not available on this site.

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

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 MALTA
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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