Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075552
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL 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
03/31/2003 ORIG-1 Approval Review (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075552_ORIGINAL APPROVAL_PACKAGE.pdf

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