Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076648
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE | 75MG;25MG | CAPSULE;ORAL | Discontinued | None | 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. |
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11/20/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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07/24/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |