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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016620
Company: ALMATICA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 50MG CAPSULE;ORAL Discontinued None Yes No
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 100MG CAPSULE;ORAL Discontinued None Yes No
MACRODANTIN NITROFURANTOIN, MACROCRYSTALLINE 25MG CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/21/2021 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016620Orig1s076lbl.pdf
01/21/2021 SUPPL-76 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016620Orig1s076lbl.pdf
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
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