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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075572
Company: NESHER PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE 15MG TABLET;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
02/27/2002 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75572ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75572ta.pdf
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